Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924493
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 15, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date May 17, 2018
Actual Study Start Date  ICMJE July 3, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometriosis
  • Irritable Bowel Syndrome
  • Visceral Syndrome
  • Visceral Hypersensitivity
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
24
Actual Study Completion Date  ICMJE February 1, 2018
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02924493
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP