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Mediterranean Diet for Endometriosis (MDIE Trial)

N/A

Waitlist Available

Led By Mathew Leonardi, M.D.

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Identified female at birth

Diagnosed with endometriosis (radiologically (ultrasound or magnetic resonance imaging (MRI)) or surgically confirmed diagnosis of endometriosis)

Must not have

History of or diagnosis of gynecologic or GI malignancy

Post-menopausal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if following a Mediterranean diet for 12 weeks can help reduce pelvic pain in endometriosis patients. One group will follow the diet while another group continues with their usual diet

Who is the study for?

This trial is for individuals assigned female at birth, aged 18-45, who have been diagnosed with endometriosis either through ultrasound or MRI, or confirmed surgically. Participants must be able to give written consent.

What is being tested?

The study is examining the impact of a Mediterranean diet on pelvic pain and quality of life in patients with endometriosis over a period of 12 weeks. It will compare results between those following this diet and those maintaining their usual diet.

What are the potential side effects?

Since the intervention involves dietary changes to adopt a Mediterranean diet, side effects may include initial digestive adjustments such as bloating or changes in bowel habits as the body adapts to new foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was identified as female at birth.

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My endometriosis was confirmed by ultrasound, MRI, or surgery.

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had cancer in my reproductive or digestive system.

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I have gone through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of a large multi-site trial measured by assessing enrolment rate, dropout rate, time to sample size, adherence (Mediterranean Diet Adherence Score), time for intervention group to follow diet, food costs and frequency/type of Adverse Events.

Secondary study objectives

If the Mediterranean Diet improves pain of patients with endometriosis assessed using a visual analog scale (VAS) as well as the Endometriosis Health Profile (EHP-30).

To assess if there is a change in the composition of the microbiota following a dietary change to the Mediterranean Diet using 16s ribosomal ribonucleic acid sequencing (McMaster Genomic Facility)

To assess whether the Mediterranean Diet can improve the concentration of peripheral inflammatory markers from baseline to study-end assessed using a 71 inflammatory marker protein array (EveTechnologies, Calgary, AB)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mediterranean DietExperimental Treatment1 Intervention

Participants enrolled in group 1 will be counselled by a dietician and asked to adopt a Mediterranean diet for a 12-week period from counselling. Participants will complete the Mediterranean Diet Adherence Score, pain questionnaires as well as quality of life questionnaires (EPH-30, SF-36, GIQLI) which have been previously validated. Participants in this group will give a baseline and final visit blood sample and stool samples to assess inflammation biomarkers as well as gut microflora

Group II: No Diet ModificationActive Control1 Intervention

Participants enrolled in group 2 will be NOT counselled by a dietician. Participants will complete the Mediterranean Diet Adherence Score, pain questionnaires as well as quality of life questionnaires (EPH-30, SF-36, GIQLI) which have been previously validated. Participants in this group will give a baseline and final visit blood sample and stool samples to assess inflammation biomarkers as well as gut microflora

0 / 5Eligibility criteria met