N/A
N=17
Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
Diarrhea Predominant Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00616200 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Very low carbohydrate diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. |
13 | — |
| SECONDARY Impact of Very Low Carbohydrate Diet on Stool Frequency |
2.6 | — |
| SECONDARY Sickness Impact Profile |
2.3 | .001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years old, male or female
- Meet Rome II Criteria for IBS-D
- Body mass index > 25 kg/m^2
- Desire to use a very low carbohydrate diet for weight loss
- Score of > 36 on the FBDSI
- Ability to understand consent form
- 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
- Age 70 years
- History of inflammatory bowel disease
- History of any gastrointestinal surgery that preceded the onset of IBS symptoms
- Pregnancy or breastfeeding
- FBDSI symptom score of ≤ 36
- Inability to understand consent form
- Diabetes requiring medications (must be controlled with diet and exercise alone).
- Chronic narcotic use for any reason
- Use of serotonin-selective reuptake inhibitors unless patient has been on a stable dose for at least 4 weeks.
- Use of any over-the-counter or prescription weight loss medications.
- Any chronic or unstable diseases (e.g., kidney disease, heart disease, or cancer) that may put the subject at increased risk from the intervention
- Any of the following baseline abnormalities of laboratory tests or physical exam findings:
- Serum creatinine > 1.5 mg/dL in men, > 1.3 mg/dL in women.
- Liver disease (AST or ALT > 2 times the upper limit of normal or total bilirubin > 1.6mg/dL).
- Blood pressure > 160/100 mm Hg.
- Fasting triglycerides > 600 mg/dL.
- Fasting serum low-density lipoprotein (LDL) cholesterol > 190 mg/dL.
Data sourced from ClinicalTrials.gov (NCT00616200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.