Irritable Bowel Syndrome


Effects of diet and genetic factors on gut dysbiosis in IBS

IRB# HUM00095067

Purpose

We are looking at the differences between people with Irritable Bowel Syndrome (IBS) and no IBS. We will be comparing a red meat diet vs vegetarian diet. We also compare IBS symptoms (diarrhea, constipation, or diarrhea alternating with constipation) with tests about how your GI tract and gut work.

Subject Eligibility

You may take part in the study if:

  • You are 21 years or older
  • You meet ROME III Criteria Assessment for IBS
    • Change of frequency in stool or form of stool
    • Abdominal pain that resolves with bowel movements
    • Experiencing these types of symptoms at least weekly for 2 months
  • Some perquisite eligibility testing is required. Please contact our study team!

You may NOT take part in the study if:

  • You have other medical problems (evaluated by study team)
  • You are pregnant or planning to become pregnant
  • You are diabetic or severely lactose-intolerant

Description

If you agree to be in this study, your participation schedule will look something like this:

  • Visit #1: (1-2 hrs) Sign Informed Consent, Medical history/height & weight, Assess eligibility for IBS or control group, Medication Review, Complete 4 questionnaires, Provide a blood sample, Review your food intake for the past 24 hours ( 24 hour Diet Recall), Be given stool kit and instructions for collection at home, Be given instructions and kit for lactulose/mannitol testing at home, Schedule the visceral pain testing (optional), Receive parking pass
  • Interim/At Home: Collect a stool sample (at home, 5-10mins), Lactulose/mannitol testing with urine collection for 6 hours (completed at home). Speak with study team twice regarding 24-hour food intake (2 unannounced phone calls by study team, 5-10 mins), Record your bowel movements for 7 days with Bristol Scale (5 mins a day)
  • Visit #2 – Visceral Pain Test (optional)

Compensation: $25 for blood sample, $25 for stool sample, $25 for urine sample, and $50 for optional visceral pain test (VPT)

Expected Recruitment End Date: February 2019

Principal Investigator: Chung Owyang, MD

Study Coordinator: Nicole Bowers, Email: nicolebo@med.umich.edu (link sends email), Phone: (734) 936-4979


A longitudinal study to identify IBS phenotypes using fecal microbiota and hydrogen breath testing

IRB# HUM00129427

Purpose

Treatments such as a nonabsorbable antibiotic called rifaximin or a diet low in FODMAP may improve symptoms in patients with irritable bowel syndrome (IBS). FODMAP is an acronym that stands for Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols. FODMAP are sugars (carbohydrates) in the foods we eat that are poorly absorbed by the gut. We believe these treatments work by affecting the intestinal bacteria in our gut. However, this has never been proven. Also, we do not yet have a way to predict who will respond best to treatments in IBS, such as rifaximin or a low FODMAP diet. We want to see if we can better classify IBS patients based on the results of tests, such as a glucose hydrogen breath test or by the composition of stool bacteria. A hydrogen breath test is looking for a condition called small intestinal bacterial overgrowth (SIBO). We also want to see if treatments for IBS lead to changes in the stool microbiome or hydrogen breath test results.

Subject Eligibility

You may take part in the study if:

  • You are between the ages of 18–100
  • You meet the Rome IV criteria for diarrhea-predominant irritable bowel syndrome
    • Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with 2 or more of the following:
      • Related to defecation
      • Associated with a change in frequency of stool
      • Associated with a change in form (appearance) of stool
      • You have undergone a colonoscopy or flexible sigmoidoscopy within the past 24 months

You may NOT take part in the study if:

  • You have Crohn’s disease, ulcerative colitis, or another inflammatory bowel disease
  • You have a history of GI tract surgery (excluding appendectomy)
  • You have been on the antibiotic rifaximin, or a low FODMAP diet
  • You are pregnant or breastfeeding

Description

If you agree to be in this study, your participation schedule will be as follows:

Visit 1 (All subjects): You will come in to determine if you are eligible to participate in this study and to complete questionnaires that determine the severity of your GI symptoms. This visit will take about 1 hour.

  • Questionnaires – you will complete eight questionnaires to look at the severity of your GI and psychological symptoms. You will go home and complete three questionnaires each day to look at the severity of your abdominal pain and bloating as well as your stool consistency and form.
  • Dietary questionnaires – you will meet with the study team to learn how to complete the dietary questionnaires. You will then go home and complete three dietary recalls over 1 week to determine your typical diet.
  • Urine pregnancy test – Women of childbearing age will undergo a urine pregnancy test.
  • Wash-out period – We will ask that you discontinue the following medications for at least 1 month prior to enrollment: narcotic pain medications (e.g. Norco, Percocet, Morphine); and probiotics. We will ask that you stop antibiotics for at least 3 months prior to enrollment. We will also ask that you avoid Pepto-Bismol for at least 2 weeks, not eat or drink for at least 8 hours and not smoke for at least 6 hours prior to the Glucose Hydrogen Breath Test.
  • You will collect three stool samples daily at home. You will be provided with a stool collection kit to collect the stool samples and mail them back to us.

Visit 2: You will be assigned to a treatment group. You have a 50:50 chance of receiving an antibiotic called rifaximin or a diet low in FODMAP. This visit will take approximately 2.5 hours.

Rifaximin group:

Visit 2:

  • Glucose Hydrogen Breath Test you will be asked to drink a sugar water drink. You will then be asked to blow into a tube every 15 minutes for 2 hours to measure whether you have overgrowth of bacteria in your small intestine.
  • You will then start on an antibiotic called rifaximin. You will take this three times per day for a total of 14 days.
  • Should you choose to participate in the optional sub-study #2, you will provide a saliva sample, which will be self-collected in a provided kit. The sample size will be about 2 mL, or about ½ teaspoon. These samples will be stored for genetic analysis related to enzymes pertaining to IBS-D and may be shared with investigators at other institutions (Karolinska Institute and IKMB Kiel) to run specialized tests. You are free to decline participation if you do not want to have your saliva sample stored. You will have the ability to accept or decline separate permission at the end of this consent document.
  • Should you choose to participate in the optional sub-study #3, you will have your blood drawn. A trained phlebotomist will collect 1 tube, a total of about 10 mL or 2 teaspoons of blood. These blood samples will be stored for future IBS-D research. You are free to decline participation if you do not want to have your blood sample stored. You will have the ability to accept or decline separate permission at the end of this consent document.
  • You will be asked to record your stool frequency and form each day online.
  • You will also record the severity of your abdominal pain and bloating each day online.
  • You will also record your diet over a 24-hour period every week

Visits 3-6: You will come back every week to monitor your symptoms and complete questionnaires. Each visit will take about 30 minutes.

  • You will continue to record your stool frequency and form each day online.
  • You will also record the severity of your abdominal pain and bloating each day online.
  • You will also record your diet over a 24-hour period every week
  • You will collect a stool sample each week in a provided stool collection kit.
  • You will be seen back at the University of Michigan every week for three weeks. We will check to see if you have any questions about the treatment plan. You will bring in the diet, symptom questionnaires and stool forms that you completed each week. You will also complete questionnaires during each visit to monitor your symptoms.
  • Should you choose to participate in the optional sub-study #3, you will have your blood drawn at Visit 6. A trained phlebotomist will collect 1 tube, a total of about 10 mL or 2 teaspoons of blood. These blood samples will be stored for future IBS-D research. You are free to decline participation if you do not want to have your blood sample stored. You will have the ability to accept or decline separate permission at the end of this consent document.

Visit 7: – You will come back at the conclusion of the study to complete questionnaires and to repeat the following tests. This visit will take about 2.5 hours.

  • Glucose Hydrogen Breath Test
  • Stool sample collection

Stool samples before, during and after you have been on this diet will be stored for future research on IBS. You are free to decline participation if you do not want to have your stool sample stored. You will have the ability to accept or decline separate permission at the end of this consent document. This will be listed as “Optional Sub-Study #1”.

Expected Recruitment End Date: September 2019

Principal Investigator: Allen Lee, MD

Study Coordinators:

Samuel Olson, olsonsa@med.umich.edu, (734) 936-4929

Deepa Chandhrasekhar, deepac@med.umich.edu, (734) 647-9994


Charting the course to a less restrictive low FODMAP diet: The reintroduction of FODMAP foods for irritable bowel syndrome (IBS)

IRB# HUM00122970

Purpose

IBS symptoms often worsen with eating, and a diet low in certain carbohydrates (the low Fermentable Oligo-, Di-, Mono-saccharides and Polyols (FODMAP) diet) is helpful for IBS symptoms, but can be difficult to follow and quite restrictive. The purpose of the study is to find out if a diet low in all FODMAPs is necessary to result in symptom improvement, or if a modified (and less restrictive) low FODMAP diet will be sufficient. The study will also measure the effect of the diets on blood and on bowel flora, which are the good bacteria that inhabit the bowels in healthy people.

Subject Eligibility

  • Subjects 18 years of age or older
  • Female subjects must not be pregnant or breastfeeding
  • Must not be on a special or restricted diet (e.g., low FODMAP)
  • Must have active IBS symptoms, (abdominal pain or discomfort that is associated with irregular bowel habits, diarrhea or constipation)
  • Have access to a computer or cell phone
  • Willing to maintain a stable dose of their IBS medication throughout the study
  • Willing to follow study dietary instructions
  • Must not have chronic pain from other conditions besides IBS
  • Must not be using any of: narcotic medications, probiotics, antibiotics or laxatives
  • Must not have history of previous surgery in the gastrointestinal tract, except appendectomy or cholecystectomy if performed more than 6 months prior to participating in the study

Description

If you decide to participate in this study and you are eligible, your participation could last approximately 15 weeks and include up to 4 visits to the study clinic. Your participation schedule will look as follows:

Visit #1 (week -2)
Screening visit for eligibility check and consenting

Screening period (weeks -2 -0)
You will undergo a screening period to determine your eligibility for the study. You will be asked to record your symptoms and stool frequency on a daily basis, and to complete a 3-day food diary.

Visit #2 (week 0)
You will receive written and verbal instructions on the low FODMAP diet from the registered dietitian (RD). The RD will perform 24 dietary recall. BMI will be recorded. A blood, stool, and urine sample will be obtained.

Open label FODMAP diet period (week 0-3)
You will start the low FODMAP diet. You will be asked to record your symptoms, stool frequency, and 3-day food diary on a daily basis.

Visit #3 (week 3)
The RD will perform 24 dietary recall. You will also be supplied with FODMAP-containing supplements for the coming weeks. BMI will be recorded. A blood, stool, and urine sample will be obtained.

FODMAP reintroduction period (weeks 3-13)
You will enter FODMAP reintroduction phase. During this period, you will take different carbohydrate (FODMAP) category each week, followed by a "washout" week, during which there is no supplement taken. You will be asked to record your symptoms, stool frequency, and 3-day food diary on a daily basis.

Visit #4 (week 13)
The RD will perform 24 dietary recall. BMI will be recorded. A blood, stool, and urine samples will be obtained.

Compensation: $100 on completing visit 2, and $250 on visit 4, a total of $350 upon completing all study visits

Expected Recruitment End Date: October 2020

Principal Investigator: Shanti L Eswaran, MD

Study Coordinator: Lina, Email: kenya@med.umich.edu Phone: (734) 764-9226


An antibody guided dietary restriction trial using Biomerica InFoods® IBS test in patients with a previous diagnosis of irritable bowel syndrome (IBS)

IRB# HUM00135388

Purpose

This is a double-blind, placebo-controlled clinical research study conducted at 2 academic sites, to demonstrate that an exclusionary diet as determined by elevated IgG levels from the Biomerica InFoods® IBS Test is associated with a reduction in IBS symptoms.

It is expected that severity of symptoms of IBS will decrease when foods that generate a positive immune response in the Biomerica InFoods® IBS test are eliminated from the diet of the IBS patient.

Subject Eligibility

  • Subjects 21 years of age or older
  • Female subjects must not be pregnant or breastfeeding
  • Must not be on a special or restricted diet (e.g., gluten-free, lactose-free, or low FODMAP)
  • Must have active IBS symptoms, (abdominal pain or discomfort that is associated with irregular bowel habits, diarrhea or constipation)
  • Have access to a computer or cell phone
  • Willing to maintain a stable dose of their IBS medication throughout the study
  • Willing to follow a food elimination diet
  • Must not have chronic pain from other conditions besides IBS
  • Must not have used narcotic medications or Rifaximin within the past 3 months
  • Must not have history of previous surgery in the gastrointestinal tract, except appendectomy or cholecystectomy if performed more than 6 months prior to participating in the study

Description

Qualified participants will be in the study for 10 weeks and will require to make 4 visits to the Ann Arbor Medical Center.

The first 2 weeks will be for eligibility assessment:

  • evaluating participant’s IBS symptom severity
  • testing positive to at least one IgG antibody food in the InFoods® IBS sensitivity
  • the food participant reports in his/her regular diet

Qualified participants will be placed in either the “Control” or “Experimental” group, and will be asked to follow an elimination diet for 8 weeks. They will be provided with instructions of the food elimination that will be constructed according to the following criteria:

  • Results of their blood test
  • The foods they report they eat

Compensation: $50 for each visit, a total of $200

Expected Recruitment End Date: May 2019

Principal Investigator: William D Chey, MD

Study Coordinator: Lina, Email: functional-GI-disorder@med.umich.edu Phone: (734) 936-2761