Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

NCT ID: NCT02924493

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2018-02-01

Brief 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

Endometriosis; Irritable Bowel Syndrome; Visceral Syndrome; Visceral Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low FODMAP diet

This group will follow a exclusion diet called low FODMAP diet, which is a diet with restriction of fermentable carbohydrates. The patients will be guided on how to avoid some foods and how to include others. The patients will follow the diet for four weeks.

Group Type: EXPERIMENTAL

Diet low in fermentable carbohydrates (low FODMAP diet)

Intervention Type: OTHER

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.

Control diet

This group will follow a placebo diet, which is designed to imitate the low FODMAP diet by restricting specific foods. However, it is randomly selected foods that will be excluded in this diet, so that it works only as a control diet. The patients in this group will also be guided how to follow the diet for four weeks.

Group Type: PLACEBO_COMPARATOR

Diet low in fermentable carbohydrates (low FODMAP diet)

Intervention Type: OTHER

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.

Interventions

Diet 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Age 18-50 years
• Fluid spoken and written Danish
• Diagnosed endometriosis (laparoscopy and/or MR-scan) at least one year ago and sufficient treated regarding medicine and surgery. Participant will be asked to bring a copy of their medical record from the hospital or from www.sundhed.dk to verify the diagnosis.
• Diagnosis of irritable bowel syndrome according to the Rome III criteria. Both previous diagnosis and undiagnosed patients are included, as long as the study group evaluates that the patient meets the Rome III criteria.
• Accept to follow a controlled exclusion diet for all meals for four weeks with only few accepted deviations from the diet.

Exclusion Criteria

• Premature menopause
• Organic bowel disease (Celiac disease, IBD, bowel endometriosis, malignant disease)
• New therapeutic interventions during study period (medical/lifestyle/psychological). Already ongoing treatment is accepted.
• Psychiatric disorder, psychotropic drugs
• Patients, who the dietician accesses are familiar with low FODMAP diet and therefore is able to identify the placebo diet
• Patients with complicated dietary needs, e.g. severe allergies or intolerances (including lactose and fructose intolerance), athletes, any type of vegetarianism or metabolic diseases
• Pregnancy or planned pregnancy during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

Diet-in-endometriosis

Identifier Type: -

Identifier Source: org_study_id