Reliable Scoring System for Constipation Management

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CMA de Bruijn et al. J Pediatr 2022; 244: 107-114. Open Access: Development of a Bowel Management Scoring Tool in Pediatric Patients with Constipation

This report describes the “newly developed and validated PBMST (Pediatric Bowel Management Scoring Tool) is a reliable tool for evaluating bowel management strategies in children with constipation.”

Key finding:

“This study shows that use of the PBMST (see below) can better guide management of childhood constipation, with its fair reproducibility indicating that it is stable over a specified time period. Indeed, consistent use of the PBMST can objectify the patient’s clinical condition over a longer period. Consequently, the score provides feedback regarding the effect of the applied bowel management strategy for each individual patient.”

From PDF version of article

My take: 6 key questions for constipation visits: stool form, anorectal pain, abdominal pain, soiling, support from parents, and social limitations.

Related blog posts:

Modified Bristol Stool Form (see link: CAM Wegh et al. JPGN 2021; 73: 210-216. The Modified Bristol Stool Form Scale: A Reliable and Valid Tool to Score Stool Consistency in Dutch (Non)Toilet-trained Toddlers)

What About the Risk of Not Intervening to Prevent Necrotizing Enterocolitis?

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J Tobias et al. J Pediatr 2022; 244; 64-71. Open Access: Bifidobacterium longum subsp. infantis EVC001 Administration Is Associated with a Significant Reduction in the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants

Editorial: MA Underwood J Pediatr 2022; 64: 14-16. Open Access: Bifidobacterium infantis, Necrotizing Enterocolitis, Death, and the Role of Parents in the Neonatal Intensive Care Unit

Methods: Nonconcurrent retrospective analysis of 2 cohorts of 483 very low birth weight (VLBW) infants not exposed and exposed to B infantis EVC001 probiotic at Oregon Health & Science University from 2014 to 2020

Key findings:

  • The cumulative incidence of NEC diagnoses decreased from 11.0% (n = 301) in the no EVC001 (unexposed) cohort to 2.7% (n = 182) in the EVC001 (exposed) cohort (P < .01); this was a 73% risk reduction of NEC
  • NEC-associated mortality decreased from 2.7% in the no EVC001 cohort to 0% in the EVC001 cohort (P = .03)
  • There was a lack of adverse events (including probiotic sepsis)

Key points from editorial:

  • “The first cohort study showing a significant decrease in necrotizing enterocolitis (NEC) with the routine administration of probiotic dietary supplements [was] more than 20 years ago”
  • “The most recent Cochrane Database systematic review 2 included 56 randomized or quasi-randomized trials in which 10 812 infants participated. Meta-analysis found evidence for decreased risk of NEC (Risk ratio [RR] 0.54)”
  • Both the AGA and ESPGHAN have recommended routine probiotics administration to preterm infants. However, the AAP recommends “against routine probiotic administration citing ‘the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population.’”
  • “Recognizing that many neonatologists have opted to adopt routine probiotic administration to infants born preterm, the recent American Academy of Pediatrics statement6 recommends that an informed consent process for utilizing probiotics. Dr. Underwood counters: “there is no mention of a need to discuss these risks and benefits by those well-informed clinicians who may not believe that the data support administering probiotics. Inclusion of parents in decision-making in the NICU improves parent satisfaction and infant outcomes.”
  • Parent and clinician resource: necsociety.org. 9 Things You Need to Know About Necrotizing Enterocolitis and NEC Facts

My take: It is hard to understand that, despite 20 years of research showing probiotics can reduce mortality and morbidity in premature infants, we have not been able to manufacture a consistent, reliable high-quality probiotic capable of meeting FDA standards.

An Alternative to Ethanol Locks (Not Available in U.S.)

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J Strauss et al. JPGN 2022; 74: 776-781. Mechanical Complications in Central Lines Using Taurolidine Versus Ethanol Lock Therapy in Children With Intestinal Failure

This retrospective study with 13 patients (10,187 catheter days [CDs]) compared ethanol locks (EL) with taurolidine locks (TL). Taurolidine is a “non-toxic, broad-spectrum antimicrobial” with growing use outside the U.S. Manufacturing issues still need to be addressed to gain FDA approval. Link: CORMEDIX RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR DEFENCATH™ CATHETER LOCK SOLUTION

Key findings from this study:

  • TL (vs EL) had lower rates of CVC breaks (1.11 vs 5.19/1000 CDs, P < 0.001), occlusions (0.83 vs 4.06/1000 CDs, P= 0.01) and repairs (1.94 vs 5.64/1000 CDs, P= 0.01)
  • There was no significant difference in CRBSI rates: 0.83/1000 CDs for TL vs 2.03/1000 CDs for EL (P= 0.25)

My take: Taurolidine, when available in U.S., may be a suitable alternative to ethanol, when available in U.S., in preventing CRBSI. In addition, taurolidine locks appear to have fewer mechanical risks.

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Yesterday’s T-shirt

The Relief Room

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This weekend, on “Wait, Wait, Don’t Tell Me” (Transcript July 2) on their ‘Bluff the Listener’ game, they highlighted three stories of a new Philadelphia tourist attraction. The true (very funny) story was regarding “The Relief Room.” A bathroom (suitably) dedicated to Philadelphia pitcher relievers and covered in memorabilia.

GONDELMAN: 45-year-old Matt Edwards, has gone above and beyond turning his home’s downstairs bathroom into a monument to his beloved Phillies.

GONDELMAN: The Relief Room, as Edwards calls the commode, is a celebration of retired Phillies relief pitchers.

GONDELMAN: Though the room is jampacked with Phillies ephemera, such as signed photographs and figurines, the area above the toilet remains largely empty. That’s because it’s reserved especially for pitchers who have played for Phillies championship teams.

GONDELMAN: Edwards did miss an opportunity for guests to declare their need for personal relief the same way that catchers deliver signals to a pitcher – throw down one finger if you need to do what the Phillies do with a late-inning lead…

GONDELMAN: …Two fingers if you need to do what the team is playing like overall.

Here’s a link to a very descriptive NY Times article/pictures: When Nature Calls, Phillies Relievers Have a Place to Go

Good News Story: The Remarkable Hepatitis B Vaccine Story

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W-Q He, GN Guo, C Li. Hepatology 2022; 75: 1566-1578. The impact of hepatitis B vaccination in the United States, 1999-2018

In the past 30 years, the hepatitis B vaccine has been included in infant immunization schedules in the U.S. The authors studied a large, comprehensive, and nationally representative data set (NHANES data from 1999-2018) to assess its efficacy.

Key findings:

  • HBV vaccination was associated with reduced risk of all-cause mortality (HR, 0.78; 95% CI, 0.68–0.90) and cancer-related mortality (HR, 0.76; 95% CI, 0.58–1.00) 
  • The highest vaccination uptake was found among those born after 1991, at 86.5%.
  • Vaccinated participants had higher prevalence of vaccine-induced immunity than the unvaccinated (47.2% vs. 7.4%). Among those born after 1991, vaccine efficacy (VE) was found at 58% (95% CI, 18%–79%) overall and 85% for those aged ≥20 years (mean age, 22), whereas no effect was found among those born prior to 1990

Context for these findings is noted in the associated editorial (pgs 1365-1367):

HBV remains one of the most deadly viruses worldwide with nearly 1 million deaths yearly and nearly 300 million people chronically-infected. The vast majority of unvaccinated children less than 1 year of age become chronically-infected. In the U.S., 98% of children acquired HBV through vertical transmission “including 26% of pediatric cases who were born in the USA or Canada”

My take: This study shows that HBV vaccine maintains strong protection for 20 years and protects against cancer and death.

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Los Poblanos Ranch, Alburquerque

Updated Microscopic Colitis Epidemiology (2011-2019)

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J Tome et al. Clin Gastroenterol Hepatol 2022; 20: 1085-1094. Open Access: The Epidemiology of Microscopic Colitis in Olmsted County, Minnesota: Population-Based Study From 2011 to 2019

Key points:

  • “The overall incidence of MC in Olmsted County, MN, increased from 1985 to 2001, stabilized between 2002 and 2010, and continues to show a plateau between 2011 and 2019.”
  • Medications associated with a risk of microscopic colitis (MC) include statins, SSRIs, PPIs, aspirin, other NSAIDs, and histamine H2-receptor antagonists within 3 months of diagnosis. “A recent US multicenter cohort study found an inverse association with PPIs and histamine H2-receptor antagonists when compared with controls with chronic diarrhea; only NSAID use was associated with MC. 31 It is plausible these medications do not cause MC, but instead aggravate diarrhea and bring the diagnosis to clinical attention.”

Related blog post/related article:

Efficacy of Sebelipase Alfa for Lysosomal Acid Lipase Deficiency

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BK Burton et al. JPGN 2022; 74: 757-764. Open Access: Long-Term Sebelipase Alfa Treatment in Children and Adults With Lysosomal Acid Lipase Deficiency

This was open-label study of enzyme replacement therapy (ERT) in 31 children and adults with lysosomal acid lipase deficiency (LALD). Sebelipase Alfa, a recombinant human lysosomal acid lipase, was FDA approved in 2015 for LALD.

Key findings:

  • Liver biopsies showed mostly improved or stable histopathology at 48 and 96 weeks versus baseline. In addition, there was modest improvement in transaminases; median ALT and AST levels changed by −42.0 and −22.0 U/L, respectively.
  • Median low-density lipoprotein cholesterol levels decreased by 52.6 mg/dL, and median high-density lipoprotein cholesterol increased by 9.8 mg/dL. Though, 55% of the study population had concomitant lipid-modifying therapy
  • Two patients tested positive for nonneutralizing, anti-drug antibodies

In the associated commentary (pgs 726-727), the authors state this study showed that “in contrast to infantile disease, ERT is not universally beneficial in individuals with attenuated disease…[and] it is impossible to predict response to ERT.” Testing for LALD is recommended for infants with hepatomegaly, poor growth, diarrhea or adrenal insufficiency. In older groups, LALD needs to be considered in those with hepatomegaly, steatosis, and dyslipidemia.

My take: There are still many questions regarding ERT’s long-term benefit in individuals with LALD, especially those with mild disease.

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From NASPGHAN Newsletter

EEN: It Only Works If You Do It

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S Mckirdy et al. JPGN 2022; 74: 801-804. The Impact of Compliance During Exclusive Enteral Nutrition on Faecal Calprotectin in Children With Crohn Disease

The expression ‘90% of Success is Showing Up’ has been attributed to Woody Allen. With dietary and medical treatments, adherence is the equivalent of showing up.

In this study, the authors measured fecal gluten immunogenic peptides (GIP), a biomarker of gluten intake, in 45 children (3– 17 years) with Crohn’s disease to assess adherence to enteral nutrition. This, in turn, was correlated with fecal calprotectin (FC) levels.

Key findings:

  • FC decreased in patients with undetectable GIP at both 33 and 54 days of EEN (mean decrease, 33 days: −743 mg/kg, 54 days: –1043 mg/kg, P< 0.001) but not in patients who had detectable GIP levels
  • At EEN completion, patients with undetectable GIP had a lower FC by 717 mg/kg compared with patients with a positive GIP result (P = 0.042) and demonstrated a greater decline from baseline FC (–69% vs +5%, P = 0.011)
  • 13% and 23% had detectable GIP levels at 33 days and 54 days respectively. It is noted that GIP levels are only indicative of short-term consumption (eg. prior 1-2 days) of gluten-containing foods

My take: Dietary therapies are really difficult for most people. This study shows that those with poor compliance are unlikely to benefit.

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Related blog post: Why I No Longer Need to Be A Billionaire

Avoidant/Restrictive Food Intake Disorder (ARFID) with Irritable Bowel Syndrome and with Inflammatory Bowel Disease

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Last week, this blog highlighted a study regarding the prevalence of ARFID in pediatric neurogastroenterology (Prevalence of Avoidant/Restrictive Food Intake Disorders in Pediatric Neurogastroenterology).

Today, this post reviews a study with 955 adult patients from 4 prospective studies who had completed the IBS Quality of Life Instrument (IBS-QOL). The 3 questions constituting the food domain were used to identify patients with reported severe food avoidance and restriction.

Key findings:

  • In total, 13.2 % of the patients reported severe food avoidance and restriction, and in these patients all aspects of quality of life were lower (P < .01) and psychological, GI, and somatic symptoms were more severe (P < .05). 

The associated editorial provides a lot of information on ARFID in this setting.

Key points:

  • “The sine qua non of ARFID is a reduction in food intake, in terms of volume and/or variety, not primarily motivated by body image disturbance”
  • “Motivations behind changes in eating in ARFID need to be 1 or more of 3 prototypical presentations: (1) fear of aversive consequences (eg, IBS symptoms), (2) a lack of interest in eating or low appetite, and (3) sensitivity to sensory characteristics of food (eg, taste, texture, smell)”
  • “Weight suppression has similar deleterious health effects as is seen in anorexia nervosa, including cardiac abnormalities and bone mineral density loss”
  • “Up to 90% of patients in IBS reporting avoidance of specific foods”
  • “To identify presence of problematic avoidant/restrictive eating, there are ARFID measures validated with cutoffs (eg, the 9-item ARFID Screen;22,23 the PARDI-ARFID questionnaire).24 Nevertheless, more research is needed on the utility of these screening measures in IBS populations”

My take: Patients with ARFID and IBS need much more careful dietary counseling. So, it is important to consider the possibility of ARFID in this patient population.

Related article: E Yelencich et al. Clin Gastroenterol Hepatol 2022; 20: 1282-1289. Open Access PDF: Avoidant Restrictive Food Intake Disorder Prevalent Among Patients With Inflammatory Bowel Disease In this cross-sectional study of adults with IBD, 28/161 (17%) had a positive ARFID risk score (>/=24). Most participants (92%) reported avoiding 1 or more foods while having active symptoms, and 74% continued to avoid 1 or more foods even in the absence of symptoms. Patients with a positive ARFID risk screen were significantly more likely to be at risk for malnutrition (60.7% vs 15.8%; P < .01)

Related blog post:

Afraid to Eat -Could be “Avoidant Restrictive Food Intake Disorder”

Increased Risk, Increased Reward (possibly) with Tofacitinib

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T Straatmijer et al. Clin Gastroenterol Hepatol 2022; Full text Pre-Proof PDF: Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: a nationwide Dutch Registry study. DOI:https://doi.org/10.1016/j.cgh.2022.04.038

Methods: Ulcerative colitis patients who failed anti-TNF treatment and initiated vedolizumab (n=83) or tofacitinib (n=65) treatment, were identified in the ICC Registry in the Netherlands.

Key findings:

  • Tofacitinib treated patients were more likely to achieve corticosteroid-free clinical remission and biochemical remission at week 12, 24 and 52 compared to vedolizumab treated patients (OR: 6.33, OR: 3.02, and OR 1.86 and OR: 3.27, OR: 1.87, and OR:1.81, respectively).
  • There was no difference in infection rate or severe adverse events.

My take: The response rates with tofacitinib were significantly better than vedolizumab at all time points; however, by 52 weeks, the differences were less pronounced. Nevertheless, the safety profile of vedolizumab is much more favorable than tofacitinib and this is a very important consideration.

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