Nutritional Intervention for Endometriosis (NCT05175248) | Clinical Trial Compass
RecruitingNot Applicable
Nutritional Intervention for Endometriosis
United States120 participantsStarted 2022-03-02
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women with a surgical, imaging, or clinical diagnosis of endometriosis
. Age 18-45 years
. Stable health condition and medications for past 3 months
. Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9
. Able to follow a plant-based diet for 12 weeks
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Biberoglu and Behrman Scale: change from baseline
Timeframe: at baseline and at 12 weeks
2
Endometriosis Health Profile (EHP-30): change from baseline
Timeframe: at baseline and at 12 weeks
3
Inflammatory biomarkers: change from baseline
Timeframe: at baseline and at 12 weeks
Trial details
NCT IDNCT05175248
SponsorPhysicians Committee for Responsible Medicine
. Smoking or drug abuse during the past six months
. 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
. Unstable medical or psychiatric illness
. Already following a plant-based diet
. Pregnant or breastfeeding, or plans of pregnancy within the study period