Clinical trial NCT02924493: Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
Official title: Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed
timeFrame: four weeks
measure: How manageable the participants experience the diet, measured by semi-quantitative questionnaire designed by the study group
timeFrame: four weeks
measure: Identification of intervention group measured by the question: "What group do you think you were assigned to?"
timeFrame: four weeks
Secondary outcomes:
measure: Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version
timeFrame: four weeks
measure: IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life
timeFrame: four weeks
measure: Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30)
timeFrame: four weeks
measure: Intake of nutrients calculated in by: The Monash University Comprehensive Food Frequency Questionnaire (CNAQ) based on the participants self-reported 7-days food registration
timeFrame: four weeks
measure: Intermenstrual pain measured by VAS scale
timeFrame: four weeks
measure: Global symptom relief measured by the question: "Did you have sufficient relief in your IBS-symptoms during the last 7 days?"
timeFrame: four weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: