Trial Outcomes & Findings for Irritable Bowel Syndrome and Control Volunteers: Diet Challenge (NCT NCT03983434)

NCT ID: NCT03983434

Last Updated: 2025-04-30

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

48 hours

Results posted on

2025-04-30

Participant Flow

Participant milestones

Participant milestones
Measure
Healthy Volunteers
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Overall Study
STARTED
17
3
9
Overall Study
COMPLETED
16
2
6
Overall Study
NOT COMPLETED
1
1
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Volunteers
n=17 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=3 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=9 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Total
n=29 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=99 Participants
3 Participants
n=107 Participants
9 Participants
n=206 Participants
28 Participants
n=7 Participants
Age, Categorical
>=65 years
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
Age, Continuous
36.3 years
STANDARD_DEVIATION 14.9 • n=99 Participants
26.4 years
STANDARD_DEVIATION 6 • n=107 Participants
36.1 years
STANDARD_DEVIATION 9.5 • n=206 Participants
35.2 years
STANDARD_DEVIATION 12.8 • n=7 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
2 Participants
n=107 Participants
7 Participants
n=206 Participants
21 Participants
n=7 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
8 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=99 Participants
3 Participants
n=107 Participants
9 Participants
n=206 Participants
29 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Asian
9 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
10 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
White
8 Participants
n=99 Participants
2 Participants
n=107 Participants
8 Participants
n=206 Participants
18 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=2 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Total Fecal Bile Acids
471.5 mcmol/48 hours
Interval 331.5 to 612.5
347 mcmol/48 hours
Interval 159.0 to 535.0
329.5 mcmol/48 hours
Interval 145.0 to 515.0

PRIMARY outcome

Timeframe: 48 hours

Population: One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing data in 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

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=1 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Total Fecal Short Chain Fatty Acids
359.8 mmol/kg
Interval 233.1 to 473.2
157.1 mmol/kg
Interval 157.1 to 157.1
276.9 mmol/kg
Interval 168.6 to 408.1

PRIMARY outcome

Timeframe: 48 hours

Population: One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing data in 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

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=1 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Individual Fecal Short Chain Fatty Acids - Acetate
255.7 mmol/kg
Interval 147.5 to 300.1
113.9 mmol/kg
Interval 113.9 to 113.9
202.5 mmol/kg
Interval 121.7 to 266.0

PRIMARY outcome

Timeframe: 48 hours

Population: One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing 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

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=6 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=1 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Individual Fecal Short Chain Fatty Acids - Propionate
59.7 mmol/kg
Interval 39.8 to 86.0
22.8 mmol/kg
Interval 22.8 to 22.8
39.1 mmol/kg
Interval 25.3 to 51.1

PRIMARY outcome

Timeframe: 48 hours

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

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=1 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Individual Fecal Short Chain Fatty Acids - Butyrate
57.5 mmol/kg
Interval 29.1 to 70.2
20.5 mmol/kg
Interval 20.5 to 20.5
37.6 mmol/kg
Interval 16.9 to 91.0

PRIMARY outcome

Timeframe: 48 hours

Population: Microbiome sequencing was completed on all collected specimens.

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.

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=7 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Fecal Microbial Population
3 units on a scale
Interval 2.75 to 3.5
3.6 units on a scale
Interval 3.2 to 3.8

PRIMARY outcome

Timeframe: 48 hours

Population: Measures of inulin evolved over time and many subjects did not have inulin measured as a fraction.

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

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=7 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=3 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Fecal Inulin
3.6 % of fructose from inulin/total fructose
Interval 0.8 to 5.4
17.1 % of fructose from inulin/total fructose
Interval 7.4 to 25.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=2 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Percent Primary Fecal Bile Acids
2.7 % of primary/total fecal bile acids
Interval 1.0 to 26.8
0.4 % of primary/total fecal bile acids
Interval 0.3 to 0.5
2.1 % of primary/total fecal bile acids
Interval 0.6 to 10.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=16 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=2 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Stool Characteristics - Stool Frequency in 4 Days
4.5 Number of bowel movements in 4 days
Interval 4.0 to 5.5
0.5 Number of bowel movements in 4 days
Interval 0.0 to 1.0
5 Number of bowel movements in 4 days
Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=73 Bowel movements
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=1 Bowel movements
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=33 Bowel movements
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Stool Characteristics - Stool Form
4 score on a scale
Interval 3.0 to 5.0
1 score on a scale
Interval 1.0 to 1.0
5 score on a scale
Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=73 Bowel movements
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=1 Bowel movements
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=33 Bowel movements
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Stool Characteristics - Ease of Passage
4 score on a scale
Interval 4.0 to 4.0
3 score on a scale
Interval 3.0 to 3.0
4 score on a scale
Interval 4.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Healthy Volunteers
n=12 Participants
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: 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.
Irritable Bowel Syndrome Patients With Constipation
n=2 Participants
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Irritable Bowel Syndrome Patients With Diarrhea
n=6 Participants
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: 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.
Energy
1887.6 kcal
Interval 1563.9 to 2507.5
2083.8 kcal
Interval 1801.3 to 2366.4
2246.4 kcal
Interval 1540.1 to 2509.8

Adverse Events

Healthy Volunteers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Irritable Bowel Syndrome Patients With Constipation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Irritable Bowel Syndrome Patients With Diarrhea

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Huiping Xu

Indiana University

Phone: 317-278-6735

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place