Clinical Trials Directory

Trials / Completed

CompletedNCT02924493

Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

Many patients with endometriosis experience extra genital and abdominal symptoms as a major part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal structure and function elicited by the endometriotic elements, which may cause a "visceral syndrome" with the above mentioned symptoms. The investigators hypothesize that dietary treatment will improve the experience of gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study investigating patients with both endometriosis and IBS, is to test the application of a low FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot study is to investigate the applicability of a placebo diet in patients with endometriosis and to investigate the compliance in both intervention group and control group. In addition, the aim is to investigate whether the participants find the diet manageable and whether they are able to identify the placebo diet.

Conditions

Interventions

TypeNameDescription
OTHERDiet low in fermentable carbohydrates (low FODMAP diet)The participants follow the diet in 4 weeks. They have been provided with some foods (bread, pasta, cereal products), but will by the rest themselves. They have been provided with lists of foods to include and foods to avoid. They have also been provided with suggestions to a 4 week meal plan, based in their individual need for energy.

Timeline

Start date
2017-07-03
Primary completion
2017-12-01
Completion
2018-02-01
First posted
2016-10-05
Last updated
2018-05-17

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02924493. Inclusion in this directory is not an endorsement.