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

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.


Condition or disease Intervention/treatment Phase
Endometriosis Irritable Bowel Syndrome Visceral Syndrome Visceral Hypersensitivity Other: Diet low in fermentable carbohydrates (low FODMAP diet) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924493


Locations
Layout table for location information
Denmark
Aarhus University Hospital
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02924493    
Other Study ID Numbers: Diet-in-endometriosis
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: October 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Endometriosis
IBS
Irritable bowel syndrome
low FODMAP diet
FODMAPs
visceral syndrome
fermentable carbohydrates
visceral hypersensitivity
cross organ effect
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Endometriosis
Hypersensitivity
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases