NCT05175248 Nutritional Intervention for Endometriosis
| NCT ID | NCT05175248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Physicians Committee for Responsible Medicine |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-03-02 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.
Eligibility Criteria
Inclusion Criteria: 1. Women with a surgical, imaging, or clinical diagnosis of endometriosis 2. Age 18-45 years 3. Stable health condition and medications for past 3 months 4. Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9 5. Able to follow a plant-based diet for 12 weeks 6. Willing to be randomly assigned to either a plant-based group or a control group that will not make any dietary changes for 12 weeks Exclusion Criteria: 1. Body mass index ≥ 40 kg/m2 2. Smoking or drug abuse during the past six months 3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 4. Unstable medical or psychiatric illness 5. Already following a plant-based diet 6. Pregnant or breastfeeding, or plans of pregnancy within the study period 7. Hysterectomy or ovariectomy 8. Fibroids, ovarian cysts, pelvic inflammatory disease 9. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease 10. Lack of English fluency 11. Unable or unwilling to participate in all components of the study 12. Evidence of an eating disorder
Contact & Investigator
Hana Kahleova, MD, PhD
PRINCIPAL INVESTIGATOR
Physicians Committee for Responsible Medicine
Frequently Asked Questions
Who can join the NCT05175248 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05175248 currently recruiting?
Yes, NCT05175248 is actively recruiting participants. Contact the research team at msutton@pcrm.org for enrollment information.
Where is the NCT05175248 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT05175248 clinical trial?
NCT05175248 is sponsored by Physicians Committee for Responsible Medicine. The principal investigator is Hana Kahleova, MD, PhD at Physicians Committee for Responsible Medicine. The trial plans to enroll 120 participants.