This single-center observational study (n=254) examined the correlation between fecal calprotectin (FC) levels with both disease extent and mucosal healing in ulcerative colitis. Mucosal healing was rated by the Mayo Endoscopic Score (MES).
Key findings:
Disease extent: FC levels were significantly lower in proctitis (440 mg/kg) as compared with left-sided colitis (840 mg/kg) or pancolitis (1,690 mg/kg)
Mucosal healing: In MES ≤1, FC levels were significantly lower in proctitis (24) compared to left-sided colitis (40) or pancolitis (85)
My take: Fecal calprotectin levels are clearly affected by the extent of disease involvement. However, the increase in calprotectin values associated with disease activity was significantly larger than the differences attributed to disease extent.
Methods: This post hoc analysis assessed data from a 12-week, randomized, double-blind, placebo-controlled phase 3 study (NCT02605837) of budesonide oral suspension (BOS) 2.0 mg twice daily in patients (n=318) aged 11–55 years with EoE and dysphagia. Coprimary efficacy outcomes were histologic (≤ 6 eosinophils per high-power field [eos/hpf]) and dysphagia symptom (≥ 30% reduction in Dysphagia Symptom Questionnaire scores from baseline) responses at week 12.
Key findings:
Histologic responses (≤ 6 and < 15 eos/hpf) were similar regardless of dilation history
Fewer BOS-treated patients with dilation history than no dilation history achieved a dysphagia symptom response (44.0% vs 59.0%)
Discussion Points:
“Esophageal dilation may provide immediate relief from dysphagia (15); symptom improvement has been observed in 95% of dilated patients with EoE (29)…[however] dilation does not affect the underlying inflammation (18).”
“A histologic response (<15 eos/hpf) to swallowed corticosteroids has also been associated with a reduced number of repeat esophageal dilations required to maintain a similar esophageal caliber compared with nonresponse (≥15 eos/hpf)…this supports swallowed corticosteroid use in patients who have undergone esophageal dilation, even in the absence of acute symptom improvement.”
“Study limitations include potential enrollment of patients with severe disease due to stringent inclusion criteria.”
My take: While dilatation alone often improves symptoms, treatment with budesonide may help reduce need for repeat dilatations.
CFD Li Wai Suen et al.Gastroenterology, Volume 170, Issue 1, 118 – 131. Early Infliximab Levels and Clearance Predict Outcomes After Infliximab Rescue in Acute Severe Ulcerative Colitis: Results From PREDICT-UC
Methods: Data, including serum and stool testing, was extracted from from 135 patients (ages 24-42) enrolled in the PREDICT-UC prospective, randomized controlled trial
Key findings:
Lower day 3 serum infliximab levels predicted infliximab failure on day 14 and colectomy by 3 months; a threshold of ≤57.9 μg/mL had 83% sensitivity, 67% specificity, 24% positive predictive value, and 97% negative predictive value for colectomy
In patients with high clearance who did not respond to the first infliximab dose, day 14 response rate was higher with a second 10 mg/kg vs 5 mg/kg dose (38% vs 11%; risk ratio, 3.43)
Day 3 fecal infliximab levels correlated with endoscopic severity and was associated with day 7 nonresponse (P = .016)
Discussion points:
“Early infliximab levels and clearance predict outcomes in ASUC. Additionally, we are the first to demonstrate that a high early infliximab clearance can be overcome by additional dosing. These results demonstrate the potential of early infliximab TDM [therapeutic drug monitoring] to guide decision-making in ASUC and for the first time provide an evidence base for intensified infliximab dosing in clinical practice.”
My take: While the authors suggest TDM as a potential strategy to overcome low levels, an alternative approach would be using higher dosing and more frequent dosing, especially as infliximab levels may not be quickly available. Higher dosing is particularly important in the pediatric age group where studies have shown that “standard” dosing of 5 mg/kg result in insufficient levels of infliximab in ~80%.
Background: “Mechanisms by which fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) drive pathophysiology of irritable bowel syndrome (IBS) are not well understood.”
Methods: 42 patients with “Rome IV diarrhea-predominant IBS (IBS-D) underwent barrier function evaluation pre- and post-LFD along with assessment of mast cell number and activation profile. Finally, fecal supernatants (FS) were administered intracolonically to wild-type mice with and without pharmacologic inhibition, toll-like receptor 4 (tlr4)–/– mice, and mast cell-deficient mice with/without mast cell reconstitution.”
Key findings:
This is a highly technical study and would recommend reviewing the findings directly (open access article).
To summarize:
“Patients with IBS-D had significant improvement in colonic barrier structure and function, mast cell number, and levels of mast cell mediators post-LFD (low FODMAP diet). The magnitude of physiological changes did not correlate with the magnitude of clinical response.”
“This study showed the complex interplay among food, microbiome, local immune activation, and epithelial physiology in IBS by demonstrating that FODMAPs increase fecal lipopolysaccharide levels, which activates colonic mast cells to causes barrier dysfunction in diarrhea-predominant IBS.”
My take: By understanding the GI effects of a low FODMAP diet in patients with IBS-D more precisely, it may improve dietary approaches as well as other treatments like mast cell stabilizers.
Background: “Obesity has historically been defined using body mass index (BMI). However, BMI does not account for adipose tissue, limiting its accuracy. The Lancet Diabetes & Endocrinology Commission created a revised obesity definition including anthropometric measures (waist circumference [WC], waist-to-hip ratio [WHR], and waist-to-height ratio [WHtR]),1 encompassing and subcategorizing preclinical obesity (excess adiposity without organ dysfunction or physical impairment) and clinical obesity (a disease).”
Methods: The authors analyzed 14,414 participants representing 237,700,000 US adults. using the 2017-2023 National Health and Nutrition Examination Survey (NHANES)
Key findings:
Survey-weighted obesity prevalence was 75.2%
Obesity was noted in 100% among adults with BMI of 30 or greater, 80.4% with BMI 25 to less than 30, and 38.5% with BMI less than 25
Discussion Points:
“These findings demonstrate the impact of anthropometric thresholds, particularly since 80.0% of adults had waist-to-height ratio [WHtR]) above 0.5. Though this value was cited by the Lancet Commission and identifies cardiometabolic risk,1,4,5 the commission emphasized that additional research was required for this cutoff.1“
My take: This is a provocative study indicating that even more U.S. adults could be considered obese when incorporating anthropometric criteria. More data is needed to assess the outcomes of this group that is considered obese with new criteria but not by using BMI criteria.
BAPS (Bochasanwasi Akshar Purushottam Swaminarayan Sanstha) Atlanta. This is a magnificent Hindu spiritual center in Lilburn. No photos are allowed inside though there are several online (see below).
A Almallouhi et al. J Pediatr Gastroenterol Nutr. 2025 DOI: 10.1002/jpn3.70316. Clinical outcome of constipation as the presenting symptom in children with celiac disease
Background: “It is not clear if CeD prevalence is higher in children with refractory and chronic constipation or not.11–15 The current guidelines from the American Gastroenterological Association (AGA) and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) do not consider constipation an indication for CeD testing in the absence of suggestive family history, growth, or developmental delay.”
Methods: This was a retrospective study (1994-2024) of children (<18 years) who presented with constipation and then diagnosed with celiac disease (CeD). There were 248 children with CeD, 177 (71%) had biopsy-confirmed CeD, and 56 (23%) were diagnosed with serology-only criteria
Key findings:
My take:
It is unclear if having constipation increases the risk of celiac disease
Many children with celiac disease also have functional disorders like irritable bowel and constipation that often continue despite a gluten-free diet
RM Califf et al. N Engl J Med 2026;394:4-6. A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA
This editorial by 12 former FDA commissioners of both Democratic and Republican administrations is sharply critical of recent policy changes at the FDA which threaten the supply of life-saving vaccines.
Here is an excerpt:
“The existing regulatory model builds public trust by encouraging open information exchange and rigorous, transparent scientific debate. Yet a memo sent last week to FDA staff will upend core policies governing vaccine development and updates…
The memo (available at https://www.biocentury.com/article/657740) was written by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), who also serves as the agency’s chief scientific officer, chief medical officer, and acting head of CBER’s office of biostatistics, as well as overseeing the division responsible for vaccine review and approval. His memo characterizes the actions of FDA scientists who express concerns about agency processes or decisions to outside parties as “unethical” and “illegal.” It calls for scientific debates to be kept within the agency “until they are ready to be made public,” and instructs staff members who disagree with the new framework to “submit your resignation letters.”..
If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes…
The new framework rejects the agency’s long-standing reliance on “immunobridging” studies for well-understood vaccines with extensive safety data. Using this approach, once a reliable correlation with effectiveness has been established, a vaccine’s ability to stimulate the immune system to produce protective antibodies can serve as a surrogate for its efficacy in helping patients avoid infections and complications from rapidly evolving viruses such as SARS-CoV-2 and influenza. Because these viruses change frequently, repeating large-scale efficacy trials for every new seasonal strain is not feasible within the time needed to update the vaccines…
Abandoning the existing methods won’t “elevate vaccine science,” as the memo asserts. It will subject vaccines to a substantially higher and more subjective approval bar. The proposed measures will slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants…Moreover, insisting on long, expensive outcomes studies for every updated formulation would delay the arrival of better-matched vaccines when new outbreaks emerge or when additional groups of patients could benefit…
The new approach would also evade public transparency, including long-standing statutory and regulatory mechanisms that enable disagreements about benefit–risk balance, clinical trial end points, trial design, and data analysis to be aired in public…
The benefits and risks of many established vaccines are well understood, and imposing the new approval requirements without meaningful new evidence could make it impossible to keep up with evolving infectious threats.
The memo asserts, incorrectly, that “we do not have reliable data” on the benefits of Covid vaccination in children. Reasonable scientists should engage in open debate about how best to shape recommendations for children at lower risk for Covid-19, but substantial evidence shows that vaccination can reduce the risk of severe disease and hospitalization in many children and adolescents…
Americans’ safety depends on a culture in which evidence is reviewed openly and staff can surface concerns, challenge leadership, and engage with external scientists without fear of reprisal.
In a nearby neighborhood, my wife and I went walking and came across a “free art” stand which looked similar to a “free little library” stand. We picked out this small piece (about 5 inches on each side).
This year was the 2nd year that I had the opportunity to give a lecture to our group that reviewed much of the important advances that happened in 2025. All of the slides are based on studies or lectures that were reviewed on my blog, gutsandgrowth. Here are some of the slides:
This year was the 2nd year that I had the opportunity to give a lecture to our group that reviewed much of the important advances that happened in 2025. All of the slides are based on studies or lectures that were reviewed on my blog, gutsandgrowth. Here are some of the slides:
It turns out that there has been a DBPC study for parachute use
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.
This year was the 2nd year that I had the opportunity to give a lecture to our group that reviewed much of the important advances that happened in 2025. All of the slides are based on studies or lectures that were reviewed on my blog, gutsandgrowth. Here are some of the slides:
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.
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