Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
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|ClinicalTrials.gov Identifier: NCT00616200|
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : November 11, 2011
Last Update Posted : October 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Predominant Irritable Bowel Syndrome||Other: Very low carbohydrate diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome: A Prospective Pilot Study|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Other: Very low carbohydrate diet
4 weeks on strictly controlled low carbohydrate diet
- Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. [ Time Frame: At the end of each of 6 study weeks ]
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.
- Impact of Very Low Carbohydrate Diet on Stool Frequency [ Time Frame: 6 Weeks ]Stool Frequency was measured as number of stools per day
- Sickness Impact Profile [ Time Frame: At the end of four week VLCD ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616200
|United States, North Carolina|
|UNC Center for Functional GI & Motility Disorders|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Douglas Drossman, MD||UNC Chapel Hill|