Dietary Changes for Fecal Incontinence
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.
This study is looking for patients who are experiencing fecal incontinence, bowel leakage, loose stool or other issues of bowel control.
- 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
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)
Expected Recruitment End Date: May 2019
Principal Investigator: Stacy Menees, MD
Study Coordinator: Deepa Chandhrasekhar, E-mail: firstname.lastname@example.org, Phone: (734) 647-9994