NCT03983434

Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Terminated NA Results posted Last updated 30 April 2025

What this trial tests

NA trial testing Inulin in IBS - Irritable Bowel Syndrome in 29 participants. Terminated before completion.

Timeline

13 August 2019

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	29
Start date	13 August 2019
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Inulin — full drug profile →

Conditions studied

• IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →

Sponsor

Indiana University

Who can join

Adults 18 to 65, any sex, with IBS - Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Fecal Bile Acids Primary · 48 hours

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

Group	Value	95% CI
Healthy Volunteers	471.5	331.5 – 612.5
Irritable Bowel Syndrome Patients With Constipation	347	159 – 535
Irritable Bowel Syndrome Patients With Diarrhea	329.5	145 – 515

Total Fecal Short Chain Fatty Acids Primary · 48 hours

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

Group	Value	95% CI
Healthy Volunteers	359.8	233.1 – 473.2
Irritable Bowel Syndrome Patients With Constipation	157.1	157.1 – 157.1
Irritable Bowel Syndrome Patients With Diarrhea	276.9	168.6 – 408.1

Individual Fecal Short Chain Fatty Acids - Acetate Primary · 48 hours

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

Group	Value	95% CI
Healthy Volunteers	255.7	147.5 – 300.1
Irritable Bowel Syndrome Patients With Constipation	113.9	113.9 – 113.9
Irritable Bowel Syndrome Patients With Diarrhea	202.5	121.7 – 266

Individual Fecal Short Chain Fatty Acids - Propionate Primary · 48 hours

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

Group	Value	95% CI
Healthy Volunteers	59.7	39.8 – 86
Irritable Bowel Syndrome Patients With Constipation	22.8	22.8 – 22.8
Irritable Bowel Syndrome Patients With Diarrhea	39.1	25.3 – 51.1

Individual Fecal Short Chain Fatty Acids - Butyrate Primary · 48 hours

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

Group	Value	95% CI
Healthy Volunteers	57.5	29.1 – 70.2
Irritable Bowel Syndrome Patients With Constipation	20.5	20.5 – 20.5
Irritable Bowel Syndrome Patients With Diarrhea	37.6	16.9 – 91

Fecal Microbial Population Primary · 48 hours

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.

Group	Value	95% CI
Healthy Volunteers	3	2.75 – 3.5
Irritable Bowel Syndrome Patients With Diarrhea	3.6	3.2 – 3.8

Fecal Inulin Primary · 48 hours

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

Group	Value	95% CI
Healthy Volunteers	3.6	0.8 – 5.4
Irritable Bowel Syndrome Patients With Diarrhea	17.1	7.4 – 25

Percent Primary Fecal Bile Acids Secondary · 48 hours

Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectrometry. Percent primary bile acids is then calculated as primary bile acids divided by total bile acids multiplied by 100.

Group	Value	95% CI
Healthy Volunteers	2.7	1 – 26.8
Irritable Bowel Syndrome Patients With Constipation	0.4	0.3 – 0.5
Irritable Bowel Syndrome Patients With Diarrhea	2.1	0.6 – 10.3

Stool Characteristics - Stool Frequency in 4 Days Secondary · 4 days

Stool characteristics will be measured using a 4 day bowel diary. Stool frequency is the total number of bowel movements in 4 days summarized on the subject level.

Group	Value	95% CI
Healthy Volunteers	4.5	4 – 5.5
Irritable Bowel Syndrome Patients With Constipation	0.5	0 – 1
Irritable Bowel Syndrome Patients With Diarrhea	5	2 – 10

Stool Characteristics - Stool Form Secondary · 4 days

Stool characteristics will be measured using a 4 day bowel diary. Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage,3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy,7=watery, summarized on the level of bowel movements.

Group	Value	95% CI
Healthy Volunteers	4	3 – 5
Irritable Bowel Syndrome Patients With Constipation	1	1 – 1
Irritable Bowel Syndrome Patients With Diarrhea	5	4 – 6

Stool Characteristics - Ease of Passage Secondary · 4 days

Stool characteristics will be measured using a 4 day bowel diary. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.

Group	Value	95% CI
Healthy Volunteers	4	4 – 4
Irritable Bowel Syndrome Patients With Constipation	3	3 – 3
Irritable Bowel Syndrome Patients With Diarrhea	4	4 – 5

Energy Secondary · 24 hours

Optional 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/). Dietary intake within a 24-hour period in 30-90 days after study enrollment were collected.

Group	Value	95% CI
Healthy Volunteers	1887.6	1563.9 – 2507.5
Irritable Bowel Syndrome Patients With Constipation	2083.8	1801.3 – 2366.4
Irritable Bowel Syndrome Patients With Diarrhea	2246.4	1540.1 – 2509.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.