Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)

Completed · Not applicable

Conditions studied: Diarrhea Predominant Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00616200

Run by

University of North Carolina, Chapel Hill

People needed

17

Starts

2009-08-01

Expected to finish

2010-05-01

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Age < 18 years or 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.

Where it is running

• UNC Center for Functional GI & Motility Disorders — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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