EndometriosisNCT02924493
Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
A study testing Diet low in fermentable carbohydrates (low FODMAP diet) in people with Endometriosis and Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Irritable Bowel Syndrome, Visceral Syndrome
- What is being tested?
- Diet low in fermentable carbohydrates (low FODMAP diet)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jul 2017to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study
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.
- Being tested
- Diet low in fermentable carbohydrates (low FODMAP diet)
- Keywords
- Endometriosis, IBS, Irritable bowel syndrome, low FODMAP diet, FODMAPs, visceral syndrome, fermentable carbohydrates, visceral hypersensitivity, cross organ effect
- Medical subject headings
- Endometriosis, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet low in fermentable carbohydrates (low FODMAP diet)Other
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 group | Role | What they receive |
|---|---|---|
| Low FODMAP diet | Experimental | 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. Receives: Other: Diet low in fermentable carbohydrates (low FODMAP diet) |
| Control diet | Placebo comparator | 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. Receives: Other: Diet low in fermentable carbohydrates (low FODMAP diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed
Measured: four weeks
How manageable the participants experience the diet, measured by semi-quantitative questionnaire designed by the study group
Measured: four weeks
Identification of intervention group measured by the question: "What group do you think you were assigned to?"
Measured: four weeks
Secondary outcomes (6)
Gastrointestinal symptoms measured by the questionnaire: The Gastrointestinal symptom rating scale (GSRS) irritable bowel syndrome (IBS) version
Measured: four weeks
IBS related quality of life measured by the questionnaire: Irritable bowel syndrome - Quality of Life
Measured: four weeks
Endometriosis related quality of life measured by the questionnaire: The Endometriosis Health Profile (EHP-30)
Measured: 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
Measured: four weeks
Intermenstrual pain measured by VAS scale
Measured: four weeks
Global symptom relief measured by the question: "Did you have sufficient relief in your IBS-symptoms during the last 7 days?"
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start3 Jul 2017
- Primary completion1 Dec 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924493
- Sponsor's protocol ID
- Diet-in-endometriosis
- Status last verified
- Oct 2017
- First submitted
- 15 Sep 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT02924493
- Acronym / sponsor ID
- Diet-in-endometriosis
- Keywords
- Endometriosis, IBS, Irritable bowel syndrome, low FODMAP diet, FODMAPs, visceral syndrome, fermentable carbohydrates, visceral hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP diet | Experimental | Other: Diet low in fermentable carbohydrates (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. |
| Control diet | Placebo comparator | Other: Diet low in fermentable carbohydrates (low FODMAP 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control diet, Low FODMAP diet |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet low in fermentable carbohydrates (low FODMAP diet) in people with Endometriosis and Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to the diet measured by a self-administered questionnaire with a percentage scale for every meal consumed (time frame: four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.