Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

NCT03983434 | Terminated Results DMC

• 2 other identifiers: 1903209172K23DK122015
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

microbiome; microbiota; short chain fatty acids; prebiotic; bile acids

Outcome Measures

Primary Outcomes (7)

• Total Fecal Bile Acids

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

  48 hours

• Total Fecal Short Chain Fatty Acids

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

  48 hours

• Individual Fecal Short Chain Fatty Acids - Acetate

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

  48 hours

• Individual Fecal Short Chain Fatty Acids - Propionate

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

  48 hours

• Individual Fecal Short Chain Fatty Acids - Butyrate

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

  48 hours

• Fecal Microbial Population

  Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is.

  48 hours

• Fecal Inulin

  Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography

  48 hours

Secondary Outcomes (4)

• Percent Primary Fecal Bile Acids

  48 hours

• Stool Characteristics - Stool Frequency in 4 Days

  4 days

• Stool Characteristics - Stool Form

  4 days

• Stool Characteristics - Ease of Passage

  4 days

Other Outcomes (1)

• Energy

  24 hours

Study Arms (3)

Healthy volunteers

EXPERIMENTAL

Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.

Dietary Supplement: Inulin

Irritable Bowel Syndrome Patients with Diarrhea

EXPERIMENTAL

Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS

Dietary Supplement: Inulin

Irritable Bowel Syndrome Patients with Constipation

EXPERIMENTAL

Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS

Dietary Supplement: Inulin

Interventions

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.

Healthy volunteers; Irritable Bowel Syndrome Patients with Constipation; Irritable Bowel Syndrome Patients with Diarrhea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
• Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

You may not qualify if:

• Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT \> 2.0x the upper limit of normal
• Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, \> 6 months prior to study initiation.
• Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.
• Any females who are pregnant or trying to become pregnant or breast-feeding
• Antibiotic usage within 3 months prior to study participation
• Prebiotic or probiotic usage within the 2 weeks prior to study initiation
• Regular use of tobacco products within the past 6 months.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Inulin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Results Point of Contact

• Title: Dr. Huiping Xu
• Organization: Indiana University

huipxu@iu.edu

317-278-6735

Study Officials

• Huiping XU

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 12, 2019
• Study Start: August 13, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Locations

US (1)