Category Archives: Pediatric Gastroenterology Intestinal Disorder

How to Improve the Value of Biologic Infusions: Reduce Lab Testing and Frequency

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T Shah et al. JPGN Reports 2026;1–5. Responsible laboratory surveillance of pediatric patients with inflammatory bowel disease on biologic infusion therapy

This retrospective single-center study with 34 pediatric patients with inflammatory bowel disease examined the laboratory costs (2020-2021) associated with monitoring biologic therapy.

Methods: “Routine laboratory studies were defined as those part of the standardized infusion protocol at SBCH and were obtained with each scheduled infusion. The following laboratory studies were considered routine/standard: complete blood count with differential, basic metabolic panel, liver function tests, amylase, lipase, erythrocyte sedimentation rate, C-reactive protein, vitamin D, iron, ferritin, vitamin B12, folate, urine hCG (if a subject was female). Other laboratory studies that were collected, but not considered routine studies included QuantiFERON-TB, and biologic drug and antibody level.”

Key findings:

  • The average hospital charge for studies obtained per infusion was $1308.36 with an average annual cost of $9543.44 per patient
  • Fifteen (6%) instances of change in clinical management were found. “Only a limited subset of the 15 laboratory studies included were utilized in making changes: biologic drug, Vitamin D, and iron level”
  • During the study, 248 infusions were administered with a “total annual charge amongst all patients in the study was $324,447”

Discussion:

  • “Our study population had well controlled disease as evident by low PCDAI and PUCAI scores…Our observations suggest the utility of routine laboratory surveillance at each biologic infusion is minimal, favoring decreased testing for IBD patients, especially those in clinical remission.”
  • “We propose obtaining laboratory tests twice a year, or with every third infusion, for patients with mild disease or in remission based on their disease activity index scores. In our small cohort of patients, this change in practice would reduce the total annual costs by 66% ($214,154.82)”

My take: It has been my practice, for most patients with IBD, to obtain labs with every other infusion (~3 times per year). Typically, I will obtain a CBC/d, CMP and CRP and obtain other labs like Vit D, GGT, Quantiferon Gold and drug level monitoring less frequently. I rarely check Vit B12, ESR, Folate, Amylase, and Lipase.

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Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

VedoKids Study: Vedolizumab for Extraintestinal Manifestations of Inflammatory Bowel Disease

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G D’Arcangelo et al. J Pediatr Gastroenterol Nutr. 2026;82:495–502. Open Access! Vedolizumab for extraintestinal manifestations in pediatric inflammatory bowel disease: Results from the VedoKids study

Background: “Since vedolizumab is a gut-selective anti-α4β7 integrin, its effect on EIMs has been a matter of debate, with relevant data lacking in pediatric IBD. A systematic review, which included three interventional studies, five non-interventional studies, and three case series, concluded that there is insufficient evidence supporting the efficacy of vedolizumab for treating pre-existing EIMs in adults.3“

Methods: This was a subgroup analysis of the pediatric VedoKids cohort, a multicenter, prospective “real-life” study of children (aged 0–18 years) with IBD treated with vedolizumab and followed through 54 weeks.

Key findings:

  • EIMs were identified in 18/142 (12.6%) children at baseline
  • Children with EIMs had an average age of diagnosis of 9 yrs compared to 12 yrs in those without EIMs
  • Children with EIMs had higher rate of pancolitis in UC and ileocolonic distribution in CD
  • Prior anti-TNF medication was noted in 16 (89%) of EIM cohort compared to 74 (60%) of non-EIM cohort
  • Concomitant medications were administered in 72% of EIM cases and to a similar number of non-EIM patients. For EIM patients, ASA were given in 7, steroids in 10, thiopurines in 4 and methotrexate in 2
  • Children with EIMs had more active disease (see below)
  • EIM resolution rate of 89%, mainly occurring within the early weeks of vedolizumab treatment

My take: While this study has several limitations, including the high rate of concomitant medications, it shows that most patients receiving vedolizumab had resolution of their EIMs. In addition, it shows that patients with EIMs had a more severe IBD phenotype.

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Pediatric Data for Mirkizumab –SHINE-1 Trial

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Briefly noted:

Jess L et al. The Lancet Gastroenterology & Hepatology 2025; 11: 100 – 109. Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial

Background: Mirikizumab, a immunoglobulin G4 monoclonal antibody, targets the p19 subunit of IL-23, with demonstrated efficacy and safety in adults with ulcerative colitis and Crohn’s disease.

Methods: This 52-week, multicenter, open-label, non-randomized, phase 2 study enrolled pediatric participants (n=26, 2 to <18 years) with moderately-to-severely active ulcerative colitis with inadequate or loss of response or intolerance to corticosteroids, immunomodulators, biologics, or JAK inhibitors.

Key findings:

  •  At week 12: 18 (69·2%) participants had a clinical response by modified Mayo score (mMS), ten (38·5%) achieved clinical remission by mMS, 14 (53·8%) achieved endoscopic remission
  • At week 12: 20 (76·9%) of the 26 participants had a clinical response based on Pediatric Ulcerative Colitis Activity Index (PUCAI), and ten (38·5%) achieved clinical remission at week 12
  • At week 52: 14 (53·8%) of 26 participants achieved mMS-based clinical response, ten (38·5%) were in mMS-based clinical remission, ten (38·5%, 95% CI 22·4–57·5) of 26 patients were in endoscopic remission
  • At week 52:  14 (53·8%) had a PUCAI-based clinical response and 13 (50·0%) were in PUCAI-based clinical remission
  • Three (12%) participants experienced serious adverse events across induction and maintenance periods (non-infective appendicitis, worsening of ulcerative colitis, and pseudarthrosis), of which one (worsening of ulcerative colitis) led to study discontinuation

My take: In this pediatric population with high prior advanced therapy exposure, there was a good response to mirikizumab. This trial which was limited by a lack of an active comparator group was started prior to the medication approval in adults. Overall, the IL-23 class of medications has emerged as an effective drug class for inflammatory bowel disease.

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    Use of Neostigmine as Adjunct for Manual Disimpaction

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    M Mostavi, S Lee, V Martin. JPGN Reports. 2026;7:55–58. When manual disimpaction isn’t enough: Case report and review of neostigmine’s role in refractory constipation management

    This was a case report of a 21 yo with  chronic constipation and likely undiagnosed autism spectrum disorder hospitalized for severe fecal retention, unresponsive to nasogastric polyethylene glycol. He underwent a manual disimpaction but due to residual stool in more proximal colon, Neostigmine was administered with good results.

    Methods: “The patient underwent manual disimpaction under general anesthesia with a large amount of hard stool removed from the rectum. He was noted to have ongoing abdominal distension with significant palpable stool more proximally. A trial of 1 mg intravenous (IV) neostigmine was given. This was done without anticholinergic co-administration due to his persistent tachycardia (HR ~ 120 s) and with close heart rate monitoring. Passive passage of stool occurred within 5 min of drug administration. Subsequently, neostigmine was titrated in additional 1 mg IV doses every 3–5 min. His heart rate remained above 90bpm. He received a total of four doses of neostigmine over 20 min. Each administration, combined with abdominal massage, produced large amounts of soft stool along with marked reduction in distension and palpable stool burden. 

    Before NG cleanout and disimpaction:

    After NG cleanout and disimpaction/Neostigmine:

    Pharmacokinetics:

    ” Neostigmine has been clinically utilized by anesthesiologists to reverse the effects of non-depolarizing neuromuscular blocking agents…In the gastrointestinal (GI) tract, the accumulation of acetylcholine in the neuromuscular junction of the small intestine and colon results in increased contractility and peristalsis, thus promoting defecation. Neostigmine is predominately administered intravenously with typical dose ranges from 0.03 to 0.07 mg/kg, up to maximum 5 mg. The peak effect typically occurs between 7 and 10 min, while the duration of action lasts approximately 55–75 min in adult patients…

    Because of its cholinergic effects on the muscarinic receptors of the cardiac parasympathetic nervous system, neostigmine results in a significant decrease in heart rate. Therefore, when neostigmine is bolused to reverse non-depolarizing paralytics at the clinically appropriate dose (~3–5 mg IV), it is always co-administered with glycopyrrolate or atropine to prevent bradycardia at a 1:1 volume ratio.”

    My take (borrowed from authors): “This case demonstrates that intravenous neostigmine can be a safe and effective adjunct to manual disimpaction in severe refractory constipation when administered in a monitored setting.”

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    Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

    Why Are Kids in U.S. Picky Eaters?

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    Helen Zoe Veit, NY Times 2/15/26: There’s a Reason American Kids Are Such Picky Eaters:

    An excerpt:

    In historical documents of all kinds, from medical treatises to diaries to school records, Americans described children as curious omnivores who appreciated bold flavors and interesting textures…

    This was unrelated to socioeconomic status — children at every income level happily ate a diversity of foods. But today, appreciation of sharp and varied flavors can be hard to find among American kids. Parenting message boards are filled with questions about getting reluctant children to eat vegetables, and kids’ menus across the country offer dishes aimed at narrow palates.

    Many adults assume that prolonged pickiness is a hard-wired stage and that kids naturally dislike many foods. But mass childhood pickiness is a modern phenomenon created largely by junk food companies that marketed products like sugary cereals as food specifically for children, convincing Americans that kids need different, easily likable foods...widespread pickiness didn’t exist until the 20th century. Before then, kids sometimes disliked individual foods, just as some adults did. But people in earlier eras didn’t think that pickiness was related to age.

    All this changed as food companies like General Foods and Nestlé poured money into designing products in laboratories to target humans’ biological instincts and make their foods very hard to refuse. By the mid-20th century, thousands of seductively sweet, salty and crunchy factory foods crowded grocery shelves, and many of them were marketed aggressively to children — from Goldfish crackers to SpaghettiOs…

    Junk food companies also started pushing portable, calorie-dense snacks…

    As marketers glorified personalized eating, family eating habits fractured. Before the mid-20th century, most family meals centered on communal food. But as kitchens filled with shelf-stable products, many Americans stopped sharing food in the same way. One 1950s mother noted that she ate whole-wheat bread, her husband ate rye bread, and her children ate white bread…Cooking had also transformed. As more food was processed in factories, meal preparation could mean warming up or even just assembling. It suddenly became feasible to “cook” separate meals for different family members...

    We’ve been told that urging kids to eat any particular dish can cause lasting aversions and dysfunctional relationships with food...

    Parents can warmly encourage children to eat family foods and avoid offering alternatives. They can also counter corporate marketing with their own enthusiastic messages about the foods they love to eat, whether it’s a crunchy salad or slippery green olives.

    My take: The advice in this article is not for everyone – especially for patients with ARFID, sensory processing disorders, and autism. Also, this problem is not solely related to ‘big food’ marketing. There are other factors shaping our eating habits. For example, one factor for many households, especially if both parents are working, is less time for meal preparation.

    Some books that may be helpful for families working through these issues:

    • Laura Jana and Jennifer Shu: Food Fights: Winning the Nutritional Challenges of Parenthood
    • Ellyn Satter: Child of Mine and Secrets of Feeding a Healthy Family
    • Keith E. Williams and Laura J. Seiverling: Broccoli Boot Camp: Basic Training for Parents of Selective Eaters

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    The Lancet Cover: Robert F Kennedy Jr: 1 year of failure

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    Here’s link to editorial: Open Access! Robert F Kennedy Jr: 1 year of failure

    A lengthy excerpt:

    “Kennedy promised a receptive and collaborative relationship, and to the public from whom he claims his mandate, he promised a new era of unbiased science without hidden conflicts of interest, secrecy, or profiteering. Radical transparency, gold-standard science, ethics, compassion, competency, and pride would restore to HHS the unimpeachable authority that the USA needs and deserves. Politicians are known to break promises, but Kennedy’s record, 1 year in, has been a failure by most measures, especially his own.

    10 days after his speech about trust and openness, HHS rescinded a 54-year-old policy of soliciting public comments for new rules and regulations, silencing the voices of many of the stakeholders he pledged to serve. Kennedy has summarily dismissed advisers and experts, communicated policy changes on pay-walled media, fired a whistleblower, and overseen the revisions of guidelines and recommendations, contradicting decades of established science, often to the benefit of industries he formerly condemned. Under Kennedy’s leadership, the National Institutes of Health (NIH) shuttered programmes studying the health effects of air pollution, HHS withheld a report linking alcohol consumption to cancer, and the Food and Drug Administration (FDA) withdrew warnings of potential harm from consuming products (such as raw milk and chlorine dioxide) falsely marketed as treatments for autism. His changes at CDC have driven 26 states to reject official guidance on vaccine policy, and in December the CDC awarded an unsolicited $1·6 million grant to conduct a vaccine study in Guinea-Bissau that raised so many ethical concerns—the design would have risked exposing thousands of unvaccinated children to hepatitis B—that it has been compared to the infamous Untreated Syphilis Study at Tuskegee.

    HHS under Kennedy has made a habit of throwing good money after bad science. Amid the Trump administration’s cuts to research funding and personnel there has been a harmful shift in priorities. Cutting-edge discoveries and clinical investigations—on subjects ranging from mRNA vaccines to diabetes and dementia—are denied crucial resources while junk science and fringe beliefs are elevated without justifiable explanation. Under Kennedy’s leadership, politicisation at the NIH, FDA, and CDC is imperilling the future of US science and innovation and throttling the public health enterprise that keeps the country safe today.

    The mechanisms maintained by the Federal Government to monitor and report health concerns such as drug overdoses, maternal mortality, and food security have been as beleaguered as the doctors and scientists who rely on them; thousands of datasets are no longer publicly available, leaving Americans—and the world—unprepared to respond to future crises. And crises are looming: in November, 2025, the first human infection (and death) from the H5N5 strain of avian flu was recorded in Washington state; pertussis, which killed 13 people in the USA in 2025, continues to spread across the country; and the measles outbreak that began in January of last year now threatens the elimination status of the USA and Mexico.”

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    Long-Term Outcomes in Pediatric Intestinal Lymphangiectasia

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    N Goret et al. J Pediatr Gastroenterol Nutr. 2026;82:398–406. Open Access! Clinical presentation, treatment, and outcome of children with primary intestinal lymphangiectasia: A national retrospective study

    This French retrospective study included 34 children (2010-2022) and had a median followup of 4.5 years.

    Key findings:

    • Edema (79%), chronic diarrhea (50%), and ascites (35%) were the main symptoms. All of the patients had hypoalbuminemia and decreased IgG
    • Thirty-one patients received a low long-chain triglycerides dietary therapy and 25 (81%) responded: 15 had a partial response and 10 a complete response. A normal diet could be reintroduced in 14 patients (45%) without relapse during the follow-up
    • A genetic variant was identified in 5 (33%) of those with a partial response to diet and in none of those with a complete response to diet. Similarly, 6 (40%) of those with a partial response had lymphedema and none in those with a complete response. Both of these were statistically significant (p  < 0.05)
    • Seven patients (21%) received parenteral nutrition for a median duration of 4 weeks (1.5–14) due to profuse diarrhea accompanied by malnutrition
    • Second-line treatment with either sirolimus or octreotide were ineffective

    Discussion/Introduction Points:

    • Regular monitoring of fat-soluble vitamin levels and essential fatty acids … is crucial during this diet to detect potential deficiencies associated with a fat-free diet.
    • The current definition is based on the presence of peripheral lymphatic malformations associated in some cases with genetic defects affecting endothelial, connective tissue, immune, or metabolic functions.24

    My take: In this cohort, the diagnosis seems uncertain in those with a mild presentation and/or ability to tolerate reintroduction of a normal diet. A few patients that I have seen with this disorder continued with very low albumin and required albumin infusions and electrolyte supplements. More stringent diagnostic criteria/genetic testing are needed for children with presumptive primary intestinal lymphangiectasia.

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    Methotrexate Tolerance and Toxicity in Pediatric Inflammatory Bowel Disease

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    E Vermeer et al. J Pediatr Gastroenterol Nutr. 2026;82:477–486. Open Access! Methotrexate toxicity and intolerance in paediatric inflammatory bowel disease: A retrospective cohort study

    This was a  a retrospective single-center cohort study, including pediatric IBD patients (n=207) initiating MTX between 2010 and 2023. The median follow-up time was 303 days.

    Key findings:

    • Methotrexate was used in combination with a biologic medication in 114 patients (55%)
    • 157 patients (75.8%) experienced at least one MTX-induced AE, with hepatotoxicity occurring in 84 patients (53.5%), myelotoxicity in 43 patients (27.4%), and nausea in 95 patients (60.5%). Most hepato- and myelotoxicity cases were categorized as grade 1 or mild (60.7% and 81.4%, respectively). 10 patients had grade 3 hepatotoxicity (ALT 195-780 U/L)
    • Nausea was reported in 46%. Fatigue was identified in 13, Headache in 6, and Alopecia in 6
    • MTX was discontinued in 60 out of 157 cases with an AE (38%), including 27 following nausea, 27 and 4 following hepatotoxicity
    • Sixty-five (43.0%) of all biochemical toxicities occurred within the first 3 months of MTX initiation
    • Strategies to manage AEs included reduced dosage, use of antiemetics or PPIs, and change in route of administration

    Discussion:

    • The authors recommend biochemical testing after initiation “at 2, 4, 8, and 12 weeks, as most actionable toxicities occurred during this period. After 3 months, laboratory assessments could potentially be spaced out to every 4–6 months instead of every 3 months for stable patients, aligning with the new Dutch guideline for monitoring MTX toxicity in rheumatology.41 More frequent testing should be reserved for patients with risk factors such as renal dysfunction, hepatotoxic co-medications, or prior toxicity.42“
    • A study limitation was “the frequent use of combination therapy, leading to a heterogeneous study population and possible overestimation of AE rates”

    My take: Methotrexate remains an important part of treatment, especially combination treatment to prevent or overcome immunogenicity. Careful monitoring and prophylactic treatments of nausea may improve durability.

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    Dr. Ajay Kaul: Intestinal Pseudo-Obstruction

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    Dr. Ajay Kaul gave our group a terrific update on chronic intestinal pseudo-obstruction (CIPO). My notes below may contain errors in transcription and in omission. Along with my notes, I have included many of his slides.

    Key points:

    CIPO = Chronic Intestinal Pseudo-Obstruction; PIPO = Pediatric Intestinal Pseudo-Obstruction
    • Several subtypes of intestinal pseudo-obstruction: myopathy, mesenchymopathy, neuropathy
    • Also, pseudo-obstruction could be inflammatory versus non-inflammatory.  In those with active inflammation, immunosuppression medications may be helpful. However, routine intestinal biopsy is not recommended
    • Gene panel can help with diagnosis
    ACTG2 is mutation associated with Megacystis-Microcolon-Intestinal Hypoperistalsis Syndrome (MMIHS)
    • Anesthesia is associated with delayed recover of bowel function
    • Malrotaion is associated with myopathic CIPO
    • Myopathic CIPO affects all bowel regions along with bladder/uterus.  Myopathic CIPO patients are often good candidates for intestinal transplantation.  Neuropathic CIPO can be isolated to one region of the bowel
    • Flares of CIPO are well-recognized but poorly described.  Often, these last for a few days and can be managed with supportive care
    • Myopathic CIPO is characterized by low amplitude phase III MMC on manometry
    • Monitoring of nutrient deficiencies with CIPO is similar to monitoring for other causes of short bowel syndrome
    • Ileostomy prolapse and diversion colitis are frequent complications.  Diversion colitis can be managed with refeeding into mucus fistula
    MIDs = Mitochondrial diseases
    • Prokinetics are not very effective. Prucalopride may help some.  Dr. Kaul often will recommend a 4-week trial and continue if helping.  However, prucalopride may contribute to suicidal ideation and families need to be aware of this
    • Intestinal transplantation is being used much less often due to better management of intestinal failure.  CCHMC only had one child undergo ITx last year.  ITx in U.S. now has an estimated 5-year survival of 60%
    • GT placement and ileostomy are frequently needed, especially if trouble tolerating full oral diet
    • Several emerging treatments including the use of intestinal organoids are being studied

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    Upadacitinib vs Risankizumab for Crohn’s Disease

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    RS Dalal et al. Clin Gastroenterol Hepatol 2026; 24: 255-257. One-Year Comparative Effectiveness and Safety of Upadacitinib vs Risankizumab for Crohn’s Disease

    This was a retrospective single-center study (n=219) assessing upadacitinib (n=67) or risankizumab (n=152) for active Crohn’s disease (CD). Treatment initiation as post-operative prevention or for non-CD indication were excluded.

    **The patients receiving upadacitinib were generally younger, had more anti-TNF/ustekinumab failures, higher CRPs, and higher HBSs compared to risankizumab-treated patients.

    Key findings:

    • After inverse probability of treatment-weighted (IPTW) analysis, most outcomes were similar between groups. However, upadacitinib-treated patients had more surgeries, adverse events, and treatment discontinuation.
    Fractions include nonintegers due to weighting, and denominators vary due to missing data.

    My take: While this study favors risankizumab over upadacitinib, most of the outcomes were fairly similar. Risankizumab may have better long-term durability. However, the observational design limits the conclusions, particularly as the upadactinib-treated patients appeared to be more refractory at baseline. A prospective head-to-head study would be more definitive.

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