Metabolomics of fecal extracts detects altered metabolic activity of gut microbiota in ulcerative colitis and irritable bowel syndrome.
Gwénaëlle Le Gall, Samah O Noor, Karyn Ridgway...
https://pubmed.ncbi.nlm.nih.gov/21761941/Actively Recruiting
Led by University of California, Los Angeles · Updated on 2026-08-12
72
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are investigating the relationship between fecal bile acids, short-chain fatty acids SCFAs, and the gut microbiota in adults with irritable bowel syndrome IBS and healthy controls. The study aims to identify specific microbiome patterns in IBS subtypes IBS with constipation and IBS with diarrhea and compare these with matched healthy volunteers. It will test if these microbiome signatures relate to fecal SCFAs, bile acids, and bacterial fermentation of an indigestible carbohydrate inulin after a dietary challenge. Participants will undergo a controlled dietary challenge involving a low fiber, high fat diet for several days, followed by a 4-day 100 g fat diet. Stool samples will be collected at multiple time points for analysis of microbiota, SCFAs, and bile acids. The intervention includes ingestion of inulin mixed in water during a clinic visit. Optional dietary follow-up using an online dietary assessment tool is also offered to some participants. Throughout the study, participants will complete bowel symptom diaries, dietary recalls, and IBS severity questionnaires. Stool samples are collected at home and during clinic visits. Physical exams, medical history, and pregnancy tests when applicable are part of screening. Researchers will measure fecal bile acid and SCFA profiles, colonic transit, and stool characteristics. The total participation lasts about a week with additional optional follow-up up to 90 days.
CONDITIONS
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
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University of California, Los Angeles
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Inulin Challenge – Biomarker Assessment | Standard Stool Biomarker Assessment (No Challenge) |
|---|---|---|
| What this approach involves | Participants ingest inulin, a fermentable fiber, then provide stool samples for measurement of bile acids, short-chain fatty acids, and analysis of gut microbiota composition. The procedure is applied to both healthy adults and IBS patients, allowing for assessment of fermentation patterns following inulin intake. | Participants provide stool samples for measurement of fecal bile acids, short-chain fatty acids, and microbiota composition under usual dietary conditions, with no deliberate inulin or fiber challenge before collection. Used in clinical practice and most biomarker studies of IBS. |
| Role in study/clinical context | Primary protocol diagnostic procedure under investigation; aims to determine how inulin influences gut fermentation and biomarker output in IBS versus controls. | Current standard for stool biomarker analysis in IBS research and diagnosis; reflects real-world testing and reference values used in clinical settings. |
| Primary purpose or clinical question | To determine whether deliberate inulin fermentation alters stool bile acids, short-chain fatty acids, and microbiota composition—and how these responses differ between IBS subtypes and healthy adults. | To characterize baseline stool biomarker profiles (bile acids, SCFAs, microbiota) in IBS and healthy individuals without altering the diet before sample collection. |
| How procedure is performed | Participants ingest a specified dose of inulin, then collect stool samples over the next 48 hours for laboratory analysis. | Participants or patients provide stool samples during their usual diet, with no requirement for fiber challenge or controlled intake before collection. |
| Evidence status / maturity | The effect of inulin challenge on fecal and microbiome biomarkers in the context of IBS is under active clinical investigation; outside of the study setting, this approach is not routinely used or validated for diagnosis or monitoring. | Stool biomarkers (bile acids, SCFAs, microbiota) have been used in both clinical and research settings to characterize IBS subtypes, but the diagnostic utility, clinical validity, and reproducibility can be limited due to natural variability in the microbiome and metabolite profiles. |
| Important limitations and uncertainties | Not all patients may tolerate inulin. The effects of a single fiber challenge may not reflect everyday dietary patterns. The relationship between changes in biomarkers and actual IBS symptoms or subtypes remains unclear. | Stool and microbiota biomarkers can fluctuate over time, and normal ranges for these markers are not firmly established for IBS diagnosis. Assessment without dietary challenge may miss dynamic metabolic or microbiome responses potentially relevant to symptoms. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility through medical history review, physical exam, and consent. They receive instructions for diet and stool collection, and complete initial questionnaires.
1 visit (in-person)
Duration - 7 days
Participants follow a controlled low fiber, high fat diet at home and consume breakfast with inulin during a clinic visit. Stool samples and symptom diaries are collected over several days.
2 clinic visits and daily home sample collection
Duration - Up to 90 days
Willing participants complete an online dietary recall tool up to 90 days after initial study to assess diet patterns further.
Remote participation
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Lead Sponsor