Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, Los Angeles

About this trial

The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin.

The target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-75

Individuals with irritable bowel syndrome (IBS)

Healthy volunteers (healthy controls) with no prior history of gastrointestinal (GI) disease or symptoms

No dietary restrictions other than vegetarian

Disqualifiers

Inflammatory bowel disease, celiac disease, or certain types of abdominal cancer, as well as those with thyroid or liver issues

Abdominal surgery or abdominal radiation within 6 months of study participation, with an exception for C-section or gallbladder removal

Use of any prescription, over the counter, or herbal medications known to affect gastrointestinal function or study interpretation, such as opioids, inflammatory drugs or certain antidepressants, within 6 months prior to study participation for healthy volunteers, or within 2 days of study participation for participants with IBS.

An exception will be permitted for limited use of stable low doses of antidepressants for individuals who have been taking them for a period greater than one month.

Trial design

Design model

Single group

Treatments tested in this trial

  • Inulin

    Dietary supplement

    Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Healthy volunteersExperimental treatment 1 intervention
Group B: Irritable Bowel Syndrome Patients with Diarrhea (IBS-D)Experimental treatment 1 intervention
Group C: Irritable Bowel Syndrome Patients with Constipation (IBS-C)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total fecal bile acids

Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry.

Time frame
48 hours
2

Total fecal short chain fatty acids

Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry

Time frame
48 hours
3

Individual fecal short chain fatty acids

Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry

Time frame
48 hours
4

Fecal microbial population

Stool samples will be be collected from participants for nucleic acid extraction, 16S allele PCR and sequencing to measure microbial communities and profiles of specimens

Time frame
48 hours

Secondary outcomes

1

Percent primary fecal bile acids

Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectrometry.

Time frame
48 hours
2

Stool characteristics

Stool characteristics will be measured using a 4 day bowel diary

Time frame
4 days

Other outcomes

1

24-hour diet (food intake) recall

24-hour dietary intake will be submitted using web-based Automated Self-Administered Dietary Assessment Tool developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24/).

Time frame
6 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.