Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT06332560
Eligibility 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
17 Years
Study:
NCT06332560
Study Brief:
Protocol Section:
NCT06332560