Evidence map›Paper›PMID 39586243›Full record

Trial reportDigestion2025

Effects of a Protease Inhibitor Camostat Mesilate on Gut Microbial Function in Patients with Irritable Bowel Syndrome: A Pilot Randomized Placebo-Controlled Study.

Motoyori Kanazawa, Kentaro Miyamoto, Michiko Kano, Kyoko Inooka, Kentaro Oka, Motomichi Takahashi, Nariyasu Mano, Shin Fukudo

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Digestion, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Motoyori KanazawaDepartment of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kentaro MiyamotoR and D Division, Central Research Institute, Miyarisan Pharmaceutical Co., Ltd., Saitama, Japan.
Michiko KanoDepartment of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kyoko InookaDepartment of Pharmacy, Miyagi Cancer Center, Natori, Japan.
Kentaro OkaR and D Division, Central Research Institute, Miyarisan Pharmaceutical Co., Ltd., Saitama, Japan.
Motomichi TakahashiR and D Division, Central Research Institute, Miyarisan Pharmaceutical Co., Ltd., Saitama, Japan.
Nariyasu ManoDepartment of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, Japan.
Shin FukudoDepartment of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIncreased fecal protease activity, which may induce visceral hypersensitivity, has been observed in patients with irritable bowel syndrome (IBS). Serine proteases modulate FK506 binding protein (FKBP)-type peptidylprolyl cis-trans isomerase (PPIase) activity associated with immune and glucocorticoid receptor functions. The aim was to investigate whether camostat mesilate (CM), a serine protease inhibitor, modifies fecal bacterial function related to FKBP-type PPIases in patients with IBS.

methodsRandomly assigned 16 patients with IBS received 200 mg po tid of CM and 16 patients received placebo for 14 days. Self-reported adequate relief (AR) as a primary endpoint, IBS Symptom Severity Scale (IBS-SSS), and colonic motor and pain thresholds to colorectal distention were assessed before and after treatment. The fecal bacterial content was inferred from 16S rRNA gene sequence data using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States and the Kyoto Encyclopedia of Genes and Genomes database.

resultsCM significantly increased the relative abundance of Streptococcus and the functional abundances of serine protease and FKBP-type PPIase FkpA, FklB and SlyD more than placebo after treatment. CM treatment was not superior to placebo in proportion of AR although colonic motor response partially changed.

conclusionCM modulated the fecal microbiome composition and functional potentials that are related to FKBP-type PPIase activity in IBS patients. These findings suggest that protease inhibitors may modify gut microbial function along with abnormal immunological and/or stress responses that underlie pathophysiology of IBS.

Indexed as

GabexateGastrointestinal MicrobiomeGuanidinesIrritable Bowel SyndromeSerine Proteinase InhibitorsAdultBacteriaDouble-Blind MethodEstersFecesFemaleHumansMaleMiddle AgedPilot ProjectsRNA, Ribosomal, 16ScamostatEstersGabexateGuanidinesRNA, Ribosomal, 16SSerine Proteinase InhibitorsIrritable bowel syndromeMicrofloraProtease inhibitor

Identifiers

PMID39586243
PMCPMC12324801

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.