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NCT Number: NCT02924493

Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

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.

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Key information

Conditions

Endometriosis Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Intestinal Diseases Irritable Bowel Syndrome Urogenital Diseases Visceral Hypersensitivity Visceral Syndrome

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet low in fermentable carbohydrates (low FODMAP diet)

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.

Primary outcomes

  1. Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed

    Time frame: four weeks

  2. How manageable the participants experience the diet, measured by semi-quantitative questionnaire designed by the study group

    Time frame: four weeks

  3. Identification of intervention group measured by the question: "What group do you think you were assigned to?"

    Time frame: four weeks

Secondary outcomes

  1. Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version

    Time frame: four weeks

  2. IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life

    Time frame: four weeks

  3. Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30)

    Time frame: four weeks

  4. Intake of nutrients calculated in by: The Monash University Comprehensive Food Frequency Questionnaire (CNAQ) based on the participants self-reported 7-days food registration

    Time frame: four weeks

  5. Intermenstrual pain measured by VAS scale

    Time frame: four weeks

  6. Global symptom relief measured by the question: "Did you have sufficient relief in your IBS-symptoms during the last 7 days?"

    Time frame: four weeks

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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