Investigating the effects of diet and therapy on endometriosis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cannabinoid-based product for gynecologic pain in endometriosis, adenomyosis, or PID

  This study tests a high-CBD, hemp-derived product against placebo in adults with gynecologic pain from endometriosis, adenomyosis, or PID over one week to see if it reduces pain and related symptoms.

  Recruiting Phase 1/2 Mclean Hospital · Belmont, Massachusetts · NCT07728695

• Good pain consultation for endometriosis

  This trial will test whether adding a 'good pain consultation' with early biopsychosocial pain education to usual care helps biological women with endometriosis manage pain and improve quality of life.

  Recruiting Sorlandet Hospital HF · Kristiansand, Agder · NCT07205614

• Effects of pelvic organ diseases on endometrial receptivity in infertile women

  This study is trying to see how conditions like adenomyosis, fibroids, and endometriosis affect the ability of the uterus to support pregnancy in women who are having trouble getting pregnant.

  Recruiting Charles University, Czech Republic · Prague · NCT06991595

• Measuring L-PGDS levels in blood, urine, vaginal fluid and endometrial tissue

  This project will test whether L-PGDS levels in blood, urine, vaginal fluid and uterine tissue differ between women with adenomyosis, other benign uterine conditions, and healthy controls.

  Recruiting Centre Hospitalier Universitaire de Nīmes · Nîmes · NCT06864494

• Improving diagnosis of endometriosis and adenomyosis using advanced analysis techniques

  This study is trying to find better ways to diagnose endometriosis and adenomyosis in women by using advanced techniques that look at genetics and imaging to help personalize treatments.

  Recruiting IRCCS San Raffaele · Catanzaro, Catanzaro and 1 other locations · NCT06572852

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

  Recruiting TriHealth Inc. · Cincinnati, Ohio · NCT06414083

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.