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
Brief Title
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
Protocol ID
NCT03983434
Lead Sponsor
Indiana University
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.
Study Period
-
Enrollment Count
29 participants
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.
Filters
IBS - Irritable Bowel Syndrome
NA
TERMINATED
ADULT
OLDER_ADULT