Irritable Bowel Syndrome (IBS)
Comparing two forms of dietary therapy to control the symptoms of irritable bowel syndrome with diarrhea (IBS-D): a randomized, controlled trial and gastrointestinal microbiome analysis
The study compares two diets that have been recommended for improving symptoms associated with IBS.
The study is seeking adults with irritable bowel syndrome with diarrhea (IBS-D) whose abdominal discomfort and diarrhea are not well controlled. After a 2-week screening period, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to receive one of two diets: Diet 1 or Diet 2, to which they will adhere for 4 weeks. In addition, stool and blood samples will be collected before and after randomization to measure relevant biomarkers.
- This study is seeking 18 years or older male and female patients with diarrhea-predominant IBS condition.
- Must NOT have constipation more than 25% of the time
- Female childbearing potential must not be pregnant
- Must not have inflammatory bowel disease (Crohn's disease, ulcerative colitis, microscopic colitis), pancreatitis, or Hirschsprung's disease, or prior bowel obstruction
- Must not have prior bowel resection (accepted is appendectomy, cholecystectomy, and polyp removal)
- Must not have uncontrolled diabetes or thyroid function, or have hepatitis, B or C, or HIV
- Must not have chronic kidney, heart, or lung disease that may prevent study completion.
- Must not have untreated cancer
- Must not take antibiotic, probiotic, or narcotic pain medication while in the study.
Expected Recruitment End Date: January 2014
Principal Investigator: Shanti Eswaran, MD
Study Coordinator: Lina E-mail: LNahlawi@med.umich.edu, Telephone: (734) 936-2761
A study to compare the use of two different diets to reduce or improve loose stools or bowel incontinence
This study will compare two diets to see which one is more effective in improving or eliminating accidental bowel leakage (which is also called fecal incontinence). One diet is using foods that are low in fermentable carbohydrates and the other diet is using foods high in fiber.
Study patients will be in the study for six weeks and will be expected to come to the investigator’s office for 4 visits, each visit lasting 1-2 hours. Subjects will be asked to record symptoms daily during the 6 weeks. This will take approximately 5 minutes per day. Patients will be given dietary counseling for 4 weeks to asses if diet can help control the symptoms they are experiencing.
Responsibilities as a study patient will include the following:
- Follow all directions given by the study staff including dietary directions
- Report the intake of all medications
- Tell the doctor about any adverse effects you have had since your last visit
- Tell the study doctor if you plan to have surgery, other medical treatment, or a medical procedure during the study
- Make no changes in your diet or lifestyle other than those specifically outlined in the study
The first two weeks, study patients will record symptoms daily to see if they will qualify for the study. The last 4 weeks, patients will be on the study diet and will record symptoms daily.
At the end of the study, study patients will be offered additional diet counseling for the alternate diet.
Follow-up survey (optional)
This study is looking for patients who are experiencing fecal incontinence, bowel leakage, loose stool or other issues of bowel control.
- This study is seeking 18 years or older male and female patients with functional fecal incontinence.
- Must have loose bowels
- Must not be pregnant
- Must not have cognitive dysfunction or be unable to understand or provide written informed consent
- Must not have inflammatory bowel disease
- Must not have a disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.)
- Must not have severe kidney or liver disease
- Must not have had previous abdominal surgery, other than appendectomy, cholecystectomy, and gynecologic/urologic surgery if performed more than six months before enrollment
- Must not be taking certain medications such as probiotics, antibiotics, and narcotics
Expected Recruitment End Date: December 2015
Principal Investigator: Stacy Menees, MD
Study Coordinator: Kenya E-mail: Kenya@med.umich.edu, Telephone: (734) 764-9226