Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

University of Aarhus

Status: Completed

Conditions: Visceral Hypersensitivity; Irritable Bowel Syndrome; Endometriosis; Visceral Syndrome

Treatments: Other: Diet low in fermentable carbohydrates (low FODMAP diet)

Study type: Interventional

Funder types: Other

Identifiers

NCT02924493

Diet-in-endometriosis

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

Low FODMAP diet

Experimental group

Description:

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.

Treatment:

Other: Diet low in fermentable carbohydrates (low FODMAP diet)

Control diet

Placebo Comparator group

Description:

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.

Treatment:

Other: Diet low in fermentable carbohydrates (low FODMAP diet)