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Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inulin
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for IBS - Irritable Bowel Syndrome focused on measuring microbiome, microbiota, short chain fatty acids, prebiotic, bile acids

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy volunteers

Irritable Bowel Syndrome Patients with Diarrhea

Irritable Bowel Syndrome Patients with Constipation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Stool characteristics
Stool characteristics will be measured using a 4 day bowel diary

Full Information

First Posted
June 6, 2019
Last Updated
August 29, 2023
Sponsor
Indiana University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03983434
Brief Title
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
Official Title
Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis. Visit 1 Volunteers will read and sign this informed consent after all questions about the study have been answered This is a screening visit and we may determine that volunteers ineligible to continue to participate in the study. Volunteers will have a medical history taken including demographics, history of symptoms and illness Volunteers will be asked about all medications A physical exam will be performed by the physician. Vital signs will be measured. Urine Pregnancy test may be done for woman in the reproductive age range. Eligible participants will be provided with a take-home lasagna meal. Participants will be given instructions and supplies for collection, storage and transportation of stool for the next visit. Participants will be provided with instructions for a low fiber, high fat diet which should be consumed for 2 days before stool collection and during the 2 days of stool collection. Instructions will also come with materials to allow participants to record diet intake during these 4 days. Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study Day 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit. Day 2-4 (at home): Participants record stool symptoms and patterns in a diary daily starting from Day 2 to Day 5. During this time, participants will be instructed to consume a low fiber diet, avoid alcohol, and start a 4-day 100 g fat diet. On the evening before Day 5, a standardized, completely digestible, and non-fermentable meal (lasagna) will be consumed which will be provided to you on Day 1. Participants will collect stool at home on Day 4 and 5 and store as per instructions provided on Visit 1. They will Day 5 (Visit 2): Participants return to the clinic on Day 5 after an overnight fast. You will receive a standard breakfast and lasanga meal with 10 g inulin (Orafti®) powder and 200 mL of water. Take-home meals will be provided (white bread sandwich with ham or cheese) to be consumed at 4 and 8 hours after breakfast. Day 6 (Visit 3): Participants will return to the clinic in order to return stool collections and the daily diaries. Participants may also submit diaries by fax or email. Day 30-90 • Optional dietary follow-up (Day 30-90): To further assess the utility of the 24 hour dietary recall, willing participants will be invited to participate in a an optional follow-up activity during which they will complete the Automated Self-Administered Dietary Assessment Tool with or without assistance of a trained interviewer. Interested volunteers will be contacted by phone and provided instructions on how to complete the tool online by the study team.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
microbiome, microbiota, short chain fatty acids, prebiotic, bile acids

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.
Arm Title
Irritable Bowel Syndrome Patients with Diarrhea
Arm Type
Experimental
Arm Description
Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS
Arm Title
Irritable Bowel Syndrome Patients with Constipation
Arm Type
Experimental
Arm Description
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total fecal bile acids
Description
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
Title
Total fecal short chain fatty acids
Description
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
Title
Individual fecal short chain fatty acids
Description
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
Title
Fecal microbial population
Description
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
Title
Fecal inulin
Description
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Percent primary fecal bile acids
Description
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
Title
Stool characteristics
Description
Stool characteristics will be measured using a 4 day bowel diary
Time Frame
4 days
Other Pre-specified Outcome Measures:
Title
24-hour diet (food intake) recall
Description
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/).
Time Frame
30 to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

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