This study aims to create an indication of the effect size during and after adherence to the low FODMAP diet to calculate a sample size for a future RCT on this subject.
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the change in abdominal symptoms, such as constipation
and fecal incontinence, measured using the Groningen DeFeC questionnaire, ought
to be filled in at the start of the diet, after the elimination period and
after the re-introduction period.
Secondary outcome
The secondary outcome is the change in quality of life measured using the
EHP-30 questionnaire, ought to be filled in at the start of the diet, after the
elimination period and after the re-introduction period.
Background summary
Endometriosis is a benign gynaecological condition defined as the presence of
endometrium-like tissue outside of the uterus with a prevalence of 7-10% within
the general population of premenopausal women. Frequent symptoms include
chronic inflammation, abdominal pain, dysmenorrhoea and subfertility. 15-22% of
the women also present bowel symptoms such as a bloated feeling and changing
stool, comparable to the symptoms experienced with irritable bowel syndrome
(IBS). Visceral hypersensitivity is a factor that seems to play a role in both
endometriosis as IBS. A curative therapy for endometriosis has not been found
yet and therefore research into optional therapies focused on symptom control
is of great value, with visceral hypersensitivity as a logical target for
intervention. A known visceral hypersensitivity targeted therapy for IBS with
significant reduction of abdominal symptoms is the low FODMAP diet. FODMAP is
an abbreviation of Fermentable Oligosaccharides, Disaccharides, Monosaccharides
and Polyols, short-chain carbohydrates found in numerous fruits, vegetables and
grains. During the diet the poorly absorbed carbohydrates are eliminated, that
otherwise cause an increase in small intestinal water volume and colonic gas
production. Doing so, the exacerbation of gastro-intestinal symptoms will
reduce and intestinal luminal distension causing abdominal pain and a bloated
feeling should be prevented, especially in those with visceral
hypersensitivity. Recent literature found a significant reduction in symptoms
in women suffering from both endometriosis and IBS after introducing the low
FODMAP diet. The common symptoms between endometriosis and IBS suggest that
this diet could be a therapy for women only suffering from endometriosis as
well. That is the reason to start this pilot study.
To our knowledge, this is the first prospective feasibility study that
evaluates the effects of the low FODMAP diet on women solely suffering from
endometriosis.
Study objective
This study aims to create an indication of the effect size during and after
adherence to the low FODMAP diet to calculate a sample size for a future RCT on
this subject.
Study design
Prospective feasibility study.
Study burden and risks
Participants will be asked to follow the low FODMAP diet with guidance from a
dietician. 4 appointments and 1 phone consult are needed for this guidance.
To follow a diet will take effort and perseverance from the patient.
The patients will also be asked to complete 2 questionnaires at three different
moments. The questionnaires focus on bowel symptoms and the quality of life. To
fill in the questionnaires will approximately take up 20 minutes every time.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
Subjects meeting all of the following criteria will be able to participate in
the study:
- Premenopausal women (>= 18 years old)
- Diagnosed with endometriosis by ultrasound, laparoscopy or MRI
- Experiencing abdominal symptoms such as abdominal pain, bloating, flatulence,
obstipation, diarrhoea, gurgling, urgency or nausea
Exclusion criteria
Subjects meeting any of the following criteria will be excluded from
participating in the study:
- Postmenopausal or aged under 18 years old
- Women not able to speak, read or write Dutch
- Gastro-intestinal co-morbidities such as food allergy, Crohn*s disease,
Ulcerative Colitis, Coeliac disease
- Diagnosed with Diabetes Mellitus
- Currently following another diet
- Currently pregnant
- Planned for surgery during the research period
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71354.015.19 |
| Other | NL8022 |