Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Approximately 10-15% of individuals in the United States have symptoms consistent with irritable bowel syndrome (IBS) which is a costly disorder and negatively impacts patient quality of life. The pathogenesis of this heterogeneous disorder is still not well understood. Patients frequently identify worsening of symptoms after meals and often cite particular foods as triggers of their IBS symptoms. Unfortunately, there is insufficient randomized clinical trial data to allow for specific dietary recommendations. Previous research has suggested a role for carbohydrate ingestion in IBS. There is also evidence for the role of the post-prandial release of 5-hydroxytryptamine (5-HT) and its turnover (as represented by the ratio of its metabolite, 5-hydroxyindoleacetic acid (5-HIAA), to 5-HT in response to a carbohydrate-rich meal, especially in those with IBS-D. As the prevalence of overweight (body mass index [BMI] > 25 kg/m2) and obesity (BMI > 30 kg/m2) has risen in recent years, very low carbohydrate diets have become popular for those attempting to lose weight. Patients with IBS, especially IBS-D, anecdotally report improvement in their gastrointestinal symptoms after initiating a very low carbohydrate diet. However, no study has investigated the effect of a very low carbohydrate diet on symptoms and quality of life in patients with IBS-D. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00616200
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date August 2009
Completion date May 2010

See also
  Status Clinical Trial Phase
Completed NCT02251483 - Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth N/A
Terminated NCT02239926 - Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D Phase 2/Phase 3
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