NCT06332560Recruiting
Pain in Endometriosis And the Relation to Lifestyle
Pain in Endometriosis And the Relation to Lifestyle: Effectiveness of a Dietary Intervention and Cognitive Behavioral Therapy in Endometriosis-associated Pain
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 13 Mar 2024
- Start date
- 4 Oct 2024
- Primary completion date
- May 2027
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Endometriosis
- NCT number
- NCT06332560
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 4 Oct 2024 to the primary completion date, May 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive or psychotropic medication
- Need for surgery during the participation in the study
Other illness
- Eating disorder
- Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease
- Self-reported celiac disease
- Diagnosed with severe mental disorder currently requiring treatment by psychiatrist
Other
- Recurrent miscarriages (\> 2)
- Vegan diet
- Smoking
- Score on FFQ \> 120
- NRS average score below 4 during the last month
- Participation in another intervention study
- Unable to speak Dutch or to understand the intervention
- Serious pain (NRS \> 4) from other origin than endometriosis
- Pregnant
- Scalp hair shorter than 4 cm
- Only applicable to patients with endometriosis
Who the study is looking for
- Confirmed diagnosis of endometriosis via ultrasound, MRI or surgery\*
- NRS pain score \> 4\*
- Age from 17 years
- Premenopausal status
- Body Mass Index (BMI) 18-30 kg/m2
- Ability to understand the explanation about the diet intervention (DI) and CBT\*
- Willing to follow the DI\*
- Willing to continue their use of food supplements
- Willing to undergo CBT\*
- Willing to collect menstrual effluent, and therefore willing to have two stop weeks from hormonal contraception (if applicable) during the study period.
Age in the registry: 17 years to - · Sex: Female · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rijnstate Hospital Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Amphia Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Jeroen Bosch Hospital (JBZ) Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.