Investigating the effects of diet and therapy on endometriosis pain
Pain in Endometriosis And the Relation to Lifestyle: Effectiveness of a Dietary Intervention and Cognitive Behavioral Therapy in Endometriosis-associated Pain
This study is testing whether an anti-inflammatory diet and therapy can help women with endometriosis feel less pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 17 Years and up |
| Sex | Female |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 5 sites ('s-Hertogenbosch and 4 other locations) |
| Trial ID | NCT06332560 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore how an anti-inflammatory diet and cognitive behavioral therapy (CBT) can alleviate pain symptoms and improve health-related quality of life in women with endometriosis. Participants will be randomized into groups receiving standard care, standard care with dietary intervention, or a combination of dietary intervention and CBT. The study will last for 12 weeks, during which participants will receive personalized dietary advice and engage in CBT sessions focused on pain mechanisms and dietary education. The trial will also assess changes in inflammatory markers and microbiome characteristics.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 17 and older with a BMI between 18-30 who experience significant pain from endometriosis.
Not a fit: Patients with severe mental disorders, chronic inflammatory diseases, or those on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new, effective non-pharmacological treatment options for managing pain in women with endometriosis.
How similar studies have performed: While the combination of dietary intervention and CBT is innovative, similar studies focusing on dietary changes for chronic pain have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Recurrent miscarriages (\> 2) * Eating disorder * Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease * Self-reported celiac disease * Vegan diet * Smoking * Use of immunosuppressive or psychotropic medication * Score on FFQ \> 120 * Diagnosed with severe mental disorder currently requiring treatment by psychiatrist * NRS average score below 4 during the last month * Participation in another intervention study * Unable to speak Dutch or to understand the intervention * Need for surgery during the participation in the study * Serious pain (NRS \> 4) from other origin than endometriosis * Pregnant * Scalp hair shorter than 4 cm * Only applicable to patients with endometriosis
Where this trial is running
's-Hertogenbosch and 4 other locations
- Jeroen Bosch Hospital (JBZ) — 's-Hertogenbosch, Netherlands (Recruiting)
- Rijnstate Hospital — Arnhem, Netherlands (Recruiting)
- Amphia — Breda, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Emma Huijs
- Email: pearl-studie.verlgyn@radboudumc.nl
- Phone: 06-29698762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.