Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial
Official title:
The Effect of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome: A Prospective Pilot Study
Verified date | October 2011 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purposes of this study are to prospectively determine the effect of a very low carbohydrate diet on quality of life and gastrointestinal symptoms in patients with diarrhea-predominant irritable bowel syndrome (IBS-D); and to determine possible physiological correlates of symptom improvement, as related to post-prandial 5-hydroxytryptamine (5-HT) release, weight loss and fiber content.
Status | Completed |
Enrollment | 17 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-70 years old, male or female 2. Meet Rome II Criteria for IBS-D 3. Body mass index > 25 kg/m^2 4. Desire to use a very low carbohydrate diet for weight loss 5. Score of > 36 on the FBDSI 6. Ability to understand consent form 7. In stable health by screening history, physical examination performed by a study physician, laboratory tests (normal blood counts, kidney function tests, liver tests, TSH). Exclusion Criteria: 1. Age < 18 years or age > 70 years 2. History of inflammatory bowel disease 3. History of any gastrointestinal surgery that preceded the onset of IBS symptoms 4. Pregnancy or breastfeeding 5. FBDSI symptom score of = 36 6. Inability to understand consent form 7. Diabetes requiring medications (must be controlled with diet and exercise alone). 8. Chronic narcotic use for any reason 9. Use of serotonin-selective reuptake inhibitors unless patient has been on a stable dose for at least 4 weeks. 10. Use of any over-the-counter or prescription weight loss medications. 11. Any chronic or unstable diseases (e.g., kidney disease, heart disease, or cancer) that may put the subject at increased risk from the intervention 12. Any of the following baseline abnormalities of laboratory tests or physical exam findings: 1. Serum creatinine > 1.5 mg/dL in men, > 1.3 mg/dL in women. 2. Liver disease (AST or ALT > 2 times the upper limit of normal or total bilirubin > 1.6mg/dL). 3. Blood pressure > 160/100 mm Hg. 4. Fasting triglycerides > 600 mg/dL. 5. Fasting serum low-density lipoprotein (LDL) cholesterol > 190 mg/dL. |
Country | Name | City | State |
---|---|---|---|
United States | UNC Center for Functional GI & Motility Disorders | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Austin GL, Dalton CB, Hu Y, Morris CB, Hankins J, Weinland SR, Westman EC, Yancy WS Jr, Drossman DA. A very low-carbohydrate diet improves symptoms and quality of life in diarrhea-predominant irritable bowel syndrome. Clin Gastroenterol Hepatol. 2009 Jun; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. | Adequate relief was measured as the primary endpoint via a single item Adequate Relief Question asking "Over the past week have you had adequate relief of your symptom experience". Higher scores represent greater levels of adequate relief over the week prior to the assessment. Participants completed this 1-item questionnaire at the end of each of weeks of the study, assessing whether they had adequate relief of their IBS symptoms for the week. A responder was defined as reporting adequate relief in at least 2 of the 4 weeks on the VLCD. |
At the end of each of 6 study weeks | |
Secondary | Impact of Very Low Carbohydrate Diet on Stool Frequency | Stool Frequency was measured as number of stools per day | 6 Weeks | |
Secondary | Sickness Impact Profile | Units of measurement on the Sickness Impact Profile were ordinal rated scored. Information on scoring use and interpretation of the Sickness Impact Profile, readers are encouraged to read Bergner et. al. 1981 - Bergner, M., Bobbit, R.A., Carter, W.B. et all (1981) the Sickness Impact Profile: Development and final revision of a health status measure. Medical Care, 19:787-805 The SIP measures sickness-related dysfunction based on behavior in order to provide a measure of health status that will aid in assessing the outcome of health care services. | At the end of four week VLCD |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02239926 -
Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D
|
Phase 2/Phase 3 | |
Completed |
NCT02251483 -
Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
|
N/A | |
Completed |
NCT01896583 -
A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
|
Phase 2 | |
Completed |
NCT01100684 -
Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
|
Phase 3 | |
Completed |
NCT02728063 -
Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance
|
N/A | |
Completed |
NCT02358694 -
Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS
|
N/A | |
Recruiting |
NCT01637714 -
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
|
N/A | |
Not yet recruiting |
NCT01373034 -
The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT01094041 -
Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT02111603 -
Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids
|
Phase 4 |