Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
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.
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.
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 with the exception of
 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

 -  Use of tobacco products within the past 6 months.