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Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

Primary Purpose

Endometriosis, Irritable Bowel Syndrome, Visceral Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Diet low in fermentable carbohydrates (low FODMAP diet)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, IBS, Irritable bowel syndrome, low FODMAP diet, FODMAPs, visceral syndrome, fermentable carbohydrates, visceral hypersensitivity, cross organ effect

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low FODMAP diet

Control diet

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version
IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life
Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30)
Intake of nutrients calculated in by: The Monash University Comprehensive Food Frequency Questionnaire (CNAQ) based on the participants self-reported 7-days food registration
Intermenstrual pain measured by VAS scale
Global symptom relief measured by the question: "Did you have sufficient relief in your IBS-symptoms during the last 7 days?"

Full Information

First Posted
September 15, 2016
Last Updated
May 16, 2018
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02924493
Brief Title
Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
Official Title
Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Irritable Bowel Syndrome, Visceral Syndrome, Visceral Hypersensitivity
Keywords
Endometriosis, IBS, Irritable bowel syndrome, low FODMAP diet, FODMAPs, visceral syndrome, fermentable carbohydrates, visceral hypersensitivity, cross organ effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low FODMAP diet
Arm Type
Experimental
Arm 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.
Arm Title
Control diet
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Diet low in fermentable carbohydrates (low FODMAP diet)
Intervention Description
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 Measure Information:
Title
Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed
Time Frame
four weeks
Title
How manageable the participants experience the diet, measured by semi-quantitative questionnaire designed by the study group
Time Frame
four weeks
Title
Identification of intervention group measured by the question: "What group do you think you were assigned to?"
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version
Time Frame
four weeks
Title
IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life
Time Frame
four weeks
Title
Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30)
Time Frame
four weeks
Title
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
Title
Intermenstrual pain measured by VAS scale
Time Frame
four weeks
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

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Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome

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