- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03983434
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anita Gupta
- Phone Number: 3179489227 317-948-9227
- Email: anigupta@iu.edu
Study Contact Backup
- Name: Alka Kadariya
- Phone Number: 317-278-9296
- Email: akadariy@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy volunteers
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.
|
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.
|
Experimental: 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 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.
|
Experimental: 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total fecal bile acids
Time Frame: 48 hours
|
Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry
|
48 hours
|
Total fecal short chain fatty acids
Time Frame: 48 hours
|
Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry
|
48 hours
|
Individual fecal short chain fatty acids
Time Frame: 48 hours
|
Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry
|
48 hours
|
Fecal microbial population
Time Frame: 48 hours
|
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
|
48 hours
|
Fecal inulin
Time Frame: 48 hours
|
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent primary fecal bile acids
Time Frame: 48 hours
|
Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectrometry.
|
48 hours
|
Stool characteristics
Time Frame: 4 days
|
Stool characteristics will be measured using a 4 day bowel diary
|
4 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour diet (food intake) recall
Time Frame: 30 to 90 days
|
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/).
|
30 to 90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1903209172
- K23DK122015 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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