Category Archives: Gastroenterology

Increase in Irritable Bowel Syndrome During COVID Pandemic

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CV Almario et al. Neurogastroenterology and Motility; https://doi.org/10.1111/nmo.70020. Trends in Prevalence of Rome IV Disorders of Gut-Brain Interaction During the COVID-19 Pandemic: Results From a Nationally Representative Sample of Over 160,000 People in the US

Methods: From May 2020 to May 2022, the authors performed a series of cross-sectional online surveys among a representative sample of adults ≥ 18 years old in the US (n=160,154). We administered Rome IV gastroduodenal and bowel DGBI questionnaires.

Key findings:

  •  During the COVID-19 pandemic, the prevalence of irritable bowel syndrome (IBS) increased from 6.1% [May 2020] to 11.0% [May 2022]
  • In addition, the prevalence of chronic idiopathic constipation (CIC) increased mildly from 6.0% [May 2020] to 6.4% [May 2022]
  • No changes in prevalence were seen for the other examined gastroduodenal and bowel disorders of gut-brain interaction (DGBI)

My take: This study identified increases in the prevalence of IBS during COVID. Increases in IBS following other enteric infections (eg. norovirus, shigella, campylobacter) has been shown previously as well.

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David Rubin: Linking Inflammatory Bowel Disease and Mental Health Through the Gut Microbiome

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At this year’s DDW, Dr. David Rubin discussed the connection between inflammatory bowel disease and mental health via the microbiome. He shared his slides: Linking Inflammatory Bowel Disease and Mental Health Through the Gut Microbiome

Here are 15 of his 37 slides:

Safe for Patients with Celiac Disease to Kiss after Partner’s Gluten Ingestion

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An excerpt from News Medical:

Researchers recruited 10 couples, each with one partner who has celiac disease, for a two-part study. In each session, the non-celiac partner ate 10 saltine crackers, and then the couple kissed for 10 seconds. In one session, the partners waited five minutes before the kiss, and in the other, they drank 4 ounces of water before kissing…

Although gluten was still found in saliva after kissing a partner who had consumed gluten and then had a glass of water, in all cases the amount was less than 20 parts per million, the level allowed in gluten-free products, which is considered safe.

“Patients with celiac disease can be more relaxed, knowing that the risk of gluten cross-contact through kissing a partner who has consumed gluten can be brought down to safe levels if food is followed by a small glass of water.”

From NBC article:

In the first scenario — waiting five minutes before kissing — two of the celiac participants had more than 20 parts per million of gluten in their saliva sample. 

In the scenario in which non-celiac partners drank 4 ounces of water before the kiss, everyone’s saliva tests contained fewer than 20 ppm of gluten. 

My take: Sounds like a fun study. Best to drink water before kissing your partner who has celiac disease.

Reference: Anne Lee. DDW Abstract Mo1242, 5/5/25: “Assessing gluten transfer via kissing; a prospective study of celiac-discordant couples”

Infection Risks with Biologic Switches: Findings from Recent Study

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Briefly noted: AJ Kruger et al. Clinical Gastroenterology and Hepatology 2025. Biologic switch timing and risk of infection in patients with ulcerative colitis/Crohn’s disease: a retrospective study

Methods: This was a “real-world practice” retrospective study (2017-2022) with 11,992 adult patients who were newly initiating a biologic therapy for UC/CD. 1,293 patients underwent a biologic switch, 64.2% of which were considered an overlapping switch (OS).

Key findings:

  • Adjusted incidence ratio IR) per 1,000 person years, for any infection, were comparable across switching groups. No significant differences in aHR of infections were found between OS and NOS [any infection aHR: 1.40, P=.17; serious infection aHR: 0.95, P=.93].

My take (borrowed from authors): “Overlapping switches were common and not associated with an increased risk of serious infection versus non-overlapping biologics.” Thus, shortened washout periods appear to pose minimal safety risks to patients while improving UC/CD therapy management.

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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..

ACCURE Trial: Appendectomy As an Adjunct Ulcerative Colitis Treatment Plus One

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YIZ Acherman, et al. The Lancet Gastroenterology & Hepatology, 2025. DOI: 10.1016/S2468-1253(25)00026-3. Open access! Appendicectomy plus standard medical therapy versus standard medical therapy alone for maintenance of remission in ulcerative colitis (ACCURE): a pragmatic, open-label, international, randomised trial

Background: “An inverse association between appendicectomy and the development of ulcerative colitis was first reported in 1987, with subsequent case-control studies confirming this observation, and suggesting a possible role of the appendix in ulcerative colitis. In 2016, our research group did a systematic review and meta-analysis of available (case-control) studies. This analysis showed that previous appendicectomy was associated with a significantly reduced risk of developing ulcerative colitis, with an overall odds ratio of 0·39 (95% CI 0·29–0·52).”

Methods:  Adult patients (n=197) with established ulcerative colitis who were in remission but had been treated for disease relapse within the preceding 12 months were randomly assigned (1:1) to undergo appendicectomy plus continued maintenance medical therapy (intervention group) or to continue maintenance medical therapy alone (control group). Approximately 25% of participants had pancolitis.

Key findings:

  • The 1-year relapse rate was significantly lower in the appendicectomy group than in the control group (36 [36%] of 99 patients vs 55 [56%] of 98 patients; relative risk 0·65 [p=0·005; adjusted p=0·002). 
Relapse Rate

My take (borrowed from the authors): “The ACCURE trial is the first randomised controlled trial evaluating the clinical effectiveness of appendicectomy in maintaining remission in patients with ulcerative colitis without advanced medical therapy (ie, biologicals or small molecules). This trial shows that laparoscopic appendicectomy, in addition to standard medical therapy, significantly reduces the relapse rates within 1 year.”

Also, NPR notes 5/5/25: NIH cuts baby ‘Safe to Sleep’ team. Here’s what parents should know

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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.

Breaking Down the New mRNA Vaccine for C. difficile

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This NEJM review describes recent developments in vaccines for C difficile.

Background: “Because the pathogenesis of C. difficile infection depends on the production of the potent toxins TcdA (toxin A) and TcdB (toxin B) by vegetative C. difficile cells, there is hope that the development of vaccines targeting these virulence factors…will be successful in limiting the development of C. difficile infection in patients receiving antibiotic treatment.2“

An excerpt:

“A trial of a vaccine composed of formalin-inactivated TcdA and TcdB purified from a highly toxigenic C. difficile strain was stopped at the first planned interim analysis on the basis of clinical futility,3 and the development of this vaccine was terminated. More recently, results were published from the Clostridium difficile Vaccine Efficacy Trial (CLOVER), a phase 3, randomized trial of a genetically detoxified C. difficile vaccine composed of recombinant TcdA and TcdB (containing targeted amino-acid substitutions to limit toxic activity) that were further detoxified by chemical means.4 Although the trial did not show a benefit with respect to the primary end point of preventing a first episode of C. difficile infection, vaccinated patients in whom C. difficile infection developed had a shorter duration of symptoms and were less likely to receive medical attention for their infection than patients who had received placebo.

In this setting, a new type of C. difficile vaccine candidate, described by Alameh, Semon, and colleagues,5 is of interest. These investigators developed a multivalent nucleoside-modified messenger RNA (mRNA) vaccine (see Key Concepts) delivered in lipid nanoparticles (LNPs)…The mRNA–LNP vaccine elicited higher antibody levels to all three vaccine targets than the recombinant vaccine with alum adjuvant. Furthermore, the mRNA–LNP vaccine provided complete protection against challenge with an intraperitoneally administered high dose of purified TcdA or TcdB: all the vaccinated mice survived, whereas all the unvaccinated mice were moribund within 2 days. The recombinant–alum vaccines protected only 20% of the vaccinated animals…

However, protection was not associated with the prevention of colonization: all the vaccinated animals shed high numbers of culturable C. difficile and had histopathological damage to intestinal tissue that was equivalent to that seen in unvaccinated animals according to analyses performed 2 days after infection. This finding suggests that protection was due to blocking of the systemic effects of the C. difficile toxins. However, additional data indicated that inclusion of the PPEP-1 antigen in the multivalent vaccine resulted in more rapid clearance of luminal toxin levels.”

My take: An effective vaccine would be a welcome advance and perhaps limit the shitty treatments we have had to date.

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Clinical Response to Risankizumab Dose Intensification for Crohn’s Disease

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RS Dalal et al. Clin Gastroenterol Hepatol 2025; 23: 662-664. Outcomes After Dose Intensification of Risankizumab for Crohn’s Disease

This retrospective study reviewed adults with Crohn’s disease (CD) who underwent dose intensification of maintenance from 360 mg every 8 weeks to every 6 weeks (n=11) or every 4 weeks (n=11).

Key findings:

  • Median time to first intensified dose was 228 days
  • Harvey Bradshaw Index (HBI) improved from a mean of 7.1 to 4.3 after 8 to 16 weeks
  • There was also improvement (not statistically significant) in mean CRP (1.64–>0.42 mg/dL) and mean calprotectin (774 –>650 mcg/g)
  • At 8 to 16 weeks, 64% (14 of 22) had a clinical response, 45% (10 of 22) achieved steroid free clinical remission

My take: This small study suggests that the majority of patients with a loss of response to standard dosing can be recaptured with dose intensification.

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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.

Over 60% of Initial Nonresponders Improve with Extended Risankizumab Therapy for Crohn’s Disease

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R Panaccione et al. Clinical Gastroenterology and Hepatology 2025; In press. Open Access! Extended Risankizumab Treatment in Patients With Crohn’s Disease Who Did Not Achieve Clinical Response to Induction Treatment

Addendum -updated reference: R Panaccione et al. Clinical Gastroenterology and Hepatology 2025; 23: 2012-2022. Open Access! Extended Risankizumab Treatment in Patients With Crohn’s Disease Who Did Not Achieve Clinical Response to Induction Treatment

Methods: Per the study design, patients who did not achieve SF/APS clinical response following induction could receive 12 weeks of extended treatment with RZB, either via administration of the higher (1200 mg) IV RZB dose evaluated in ADVANCE and MOTIVATE or by initiation of SC RZB at doses (180 mg and 360 mg) used in FORTIFY maintenance therapy.

Key findings:

  • Over 60% of initial nonresponders achieved clinical response with extended RZB treatment. These patients also demonstrated improved clinical and endoscopic outcomes during the extended treatment period, which were sustained or continued to improve during maintenance.

My take: While there is a very good response with initial risankizumab therapy in Crohn’s disease, it looks like judgment on response needs to wait until 24 weeks as there are many who do not respond at 12 weeks who will subsequently respond to treatment.

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Do Setons Improve Outcomes in Anti-TNF Treatment for Fistulas?

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J McCurdy et al. AP&T 2025; https://doi.org/10.1111/apt.70081. The Impact of Setons on Perianal Fistula Outcomes in Patients With Crohn’s Disease Treated With Anti-TNF Therapy: A Multicentre Study

This study included 221 patients — 81 with setons and 140 without setons. Patients were treated with their first anti-TNF therapy for perianal fistulizing Crohn’s disease (PFCD) after undergoing a pelvic MRI between 2005 and 2022 from 6 North American centers. Our primary outcome was major adverse fistula outcome (MAFO), a composite of repeat local surgical intervention, hospitalization, or fecal diversion for PFCD.

Key findings:

  • Patients with setons had similar rates of MAFO (HR 1.23; 95% CI, 0.68–2.21) and fistula remission at 6 months (OR, 0.81; 95% CI, 0.41–1.59) and 12 months (OR, 0.63; 95% CI, 0.31–1.27) compared to patients without setons
  • In patients with abscesses, there were lower rates of MAFO (HR, 0.49; 95% CI, 0.19–1.25) but not statistically significant in patients with setons

My take: This study indicates that seton placement may not be needed in patients who are starting anti-TNF therapy with fistulizing disease, especially if there is not an abscess present.

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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.

Competition for Competitive Acid Blockers

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Thanks to Ben Gold for the reference in today’s post.

J-H Oh et al. Am J Gastroenterol 2025; DOI: 10.14309/ajg.0000000000002929 Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis

Introduction: “Unlike PPIs, metabolism of zastaprazan in not dependent on CYP2C19, and it does not require enteric coating due to its acid stability. While PPIs bind irreversibly only to active proton pumps, zastaprazan can bind reversibly and competitively to both active and inactive proton pumps. Moreover, as prodrugs, PPIs necessitate activation into their active form within acidic conditions, typically requiring a regimen of 3-5 consecutive days of dosing…By contrast, P-CABs deliver a rapid onset of action and complete efficacy from the initial dose, as they can directly inhibit proton pumps.”

Methods: A phase III, multicenter, randomized, double-blind, noninferiority clinical study was conducted with 300 subjects (>19 yrs) with confirmed erosive esophagitis compared daily zastaprazan (20 mg) to esomeprazole (40 mg)

Key findings:

  • The cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) (P = 0.178) for esomeprazole.
  • The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026)

My take: Zastaprazan had higher healing rates at 4 weeks; results at 8 weeks were similar. This phase 3 study suggests that there will be other CABs besides vonoprazan approved for treating acid-related disorders.

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