Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 9:46 AM
Study NCT ID:
NCT03983434
Status:
TERMINATED
Last Update Posted:
2025-04-30
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
Sponsor:
Indiana University
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study physician left the university
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DK122015 | NIH | None | https://reporter.nih.gov/quic… | View |