Actively Recruiting
Pain in Endometriosis And the Relation to Lifestyle
Led by Radboud University Medical Center · Updated on 2025-08-11
250
Participants Needed
5
Research Sites
134 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet and cognitive behavioral therapy (CBT) on pain symptoms, health related quality of life and the effect on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome in women with endometriosis. In addition, we want to investigate the differences in stress (measured by hair cortisol levels), inflammatory markers in peripheral blood, menstrual effluent, and the vaginal and intestinal microbiome between persons without and with endometriosis. Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet intervention, or standard care, an anti-inflammatory diet intervention and CBT or CBT alone. Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines or CBT or a combination of both interventions for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms (and diet).
CONDITIONS
Official Title
Pain in Endometriosis And the Relation to Lifestyle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of endometriosis via ultrasound, MRI, or surgery
- NRS pain score greater than 4
- Age 17 years or older
- Premenopausal status
- Body Mass Index (BMI) between 18 and 30 kg/m2
- Ability to understand the diet intervention and CBT explanation
- Willingness to follow the anti-inflammatory diet
- Willingness to continue use of food supplements
- Willingness to undergo cognitive behavioral therapy
- Willingness to collect menstrual effluent, including two stop weeks from hormonal contraception if applicable
You will not qualify if you...
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More than 2 recurrent miscarriages
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Eating disorder
-
Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome, or other chronic inflammatory disease
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Self-reported celiac disease
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Following a vegan diet
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Smoking
-
Use of immunosuppressive or psychotropic medication
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Food Frequency Questionnaire (FFQ) score greater than 120
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Diagnosed with severe mental disorder currently requiring psychiatric treatment
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Average NRS pain score below 4 during the last month
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Participation in another intervention study
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Unable to speak Dutch or understand the intervention
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Need for surgery during study participation
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Experiencing serious pain from causes other than endometriosis
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Pregnant
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Scalp hair shorter than 4 cm
*Only applicable to patients with endometriosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Jeroen Bosch Hospital (JBZ)
's-Hertogenbosch, Netherlands
Actively Recruiting
2
Rijnstate Hospital
Arnhem, Netherlands
Actively Recruiting
3
Amphia
Breda, Netherlands
Actively Recruiting
4
Catharina Hospital
Eindhoven, Netherlands
Actively Recruiting
5
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
Research Team
E
Emma Huijs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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