Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT02924493
• Recruitment Status: Completed
• First Posted: October 5, 2016
• Last Update Posted: May 17, 2018
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Tracking Information

• First Submitted Date: September 15, 2016
• First Posted Date: October 5, 2016
• Last Update Posted Date: May 17, 2018
• Actual Study Start Date: July 3, 2017
• Actual Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2016)

• Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed [ Time Frame: four weeks ]
• How manageable the participants experience the diet, measured by semi-quantitative questionnaire designed by the study group [ Time Frame: four weeks ]
• Identification of intervention group measured by the question: "What group do you think you were assigned to?" [ Time Frame: four weeks ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 3, 2016)

• Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version [ Time Frame: four weeks ]
• IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life [ Time Frame: four weeks ]
• Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30) [ Time Frame: four weeks ]
• 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 ]
• Intermenstrual pain measured by VAS scale [ Time Frame: four weeks ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
• Official Title: Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Endometriosis
• Irritable Bowel Syndrome
• Visceral Syndrome
• Visceral Hypersensitivity

Intervention

Other: 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.

Study Arms

• Experimental: 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.
  Intervention: Other: Diet low in fermentable carbohydrates (low FODMAP diet)
• Placebo Comparator: 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.
  Intervention: Other: Diet low in fermentable carbohydrates (low FODMAP diet)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2017): 22
• Original Estimated Enrollment (submitted: October 3, 2016): 24
• Actual Study Completion Date: February 1, 2018
• Actual Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02924493
• Other Study ID Numbers: Diet-in-endometriosis
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Aarhus
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Aarhus
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Aarhus
• Verification Date: October 2017