Evidence map›Paper›PMID 42487516›Full record

Trial reportAlimentary pharmacology & therapeutics2026

Clinical Trial: Multi-Strain Probiotic Improves Bile Acid Profile, Microbiome, and Metabolomic Parameters in Patients With History of Bile Acid Malabsorption-A Randomized, Controlled Trial.

John A Damianos, Ayah Matar, Paula Carlson, Irene Busciglio, Kara J Jencks, Stephen Johnson, Ruben A Mars, Purna C Kashyap, W Scott Harmsen, Michael Camilleri

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

10 authors.

John A DamianosClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID https://orcid.org/0000-0002-2197-4977
Ayah MatarClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID https://orcid.org/0009-0009-7856-7043
Paula CarlsonClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Irene BusciglioClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Kara J JencksClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Stephen JohnsonDivision of Computational Biology, Mayo Clinic, Rochester, Minnesota, USA.
Ruben A MarsClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Purna C KashyapClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
W Scott HarmsenDivision of Computational Biology, Mayo Clinic, Rochester, Minnesota, USA.
Michael CamilleriClinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID https://orcid.org/0000-0001-6472-7514

Funding

Mechanisms of alteration of GI physiology by gut microbesR01DK114007 · NIDDK · MAYO CLINIC ROCHESTER · PI Purna C Kashyap · 2017 to 2026
$4.7M
MECHANISMS OF VISCERAL PAIN DRIVEN BY SMALL INTESTINAL MICROBIOTAR01DK138818 · NIDDK · MAYO CLINIC ROCHESTER · PI Arthur Beyder, Purna C Kashyap · 2023 to 2026
$3.9M
ExeGi PharmaNIDDK NIH HHS R01 DK114007NIDDK NIH HHS R01 DK138818
6 · The paper itself

Abstract

backgroundBile acid (BA) malabsorption (BAM) is a common cause of chronic diarrhoea and may occur in some patients due to abnormalities of the gut microbiota. Effects of probiotics on faecal secretory BAs, particularly the primary BA, chenodeoxycholic acid, are unclear. AIM/

methodsWe conducted a randomized, double-blind, placebo-controlled trial of the De Simone formulation 8-strain probiotic in 24 patients previously diagnosed with BAM. Patients were randomized to 3 weeks of the probiotic (900 billion bacteria) or placebo (maltose), both administered three times daily. Symptoms, serum 7αC4, faecal primary BAs, intestinal permeability by

resultsData from 22 patients were included. Probiotic supplementation was associated with a significant decrease in % faecal primary BAs (chenodeoxycholic acid and cholic acid) with median change from baseline -5.7 [IQR -10.3, 0.9]% compared to 9.8 [IQR 0.2, 20.6]% on placebo (p = 0.012). The faecal microbiome was significantly different in the probiotic group after intervention, driven by probiotic-specific species. There were no significant differences in symptoms, intestinal permeability, or SCFA. However, there was a numerical difference in the changes from baseline in 0-2 h

conclusionsThe De Simone formulation probiotic induced significant microbiome and metabolome changes in patients with BAM, ultimately leading to a decrease in % faecal primary BAs and possible reduction in intestinal permeability. CLINICAL TRIALS: gov registration NCT #06609148, January 2, 2025.

Indexed as

Bile Acids and SaltsGastrointestinal MicrobiomeMalabsorption SyndromesProbioticsAdultAgedDiarrheaDouble-Blind MethodFecesFemaleHumansIntestinal Barrier FunctionMaleMiddle AgedSteatorrheaTreatment OutcomeBile Acids and Saltschenodeoxycholicdiarrhoeapermeabilityprimary bile acid

Identifiers

PMID42487516
PMCPMC13511384

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.