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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
MDIE Trial 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.Check my eligibility
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.See study design
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.
MDIE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was identified as female at birth.
Select...
My endometriosis was confirmed by ultrasound, MRI, or surgery.
Select...
I am between 18 and 45 years old.
MDIE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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)
MDIE 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
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Who is running the clinical trial?
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,977 Total Patients Enrolled
McMaster UniversityLead Sponsor
886 Previous Clinical Trials
2,598,448 Total Patients Enrolled
3 Trials studying Endometriosis
70 Patients Enrolled for Endometriosis
Mathew Leonardi, M.D.Principal InvestigatorMcMaster University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which individuals meet the criteria for participation in this medical study?
"To qualify for this research, individuals must have a diagnosis of endometriosis and fall between the ages of 18 and 45. A total of 24 participants will be enrolled in this trial."
Answered by AI
Are there any current opportunities for potential participants to enroll in this trial?
"As per clinicaltrials.gov, the recruitment for this trial is presently closed. The study was initially posted on August 22nd, 2023, and last revised on April 18th, 2024. Despite this trial not actively seeking participants currently, there are up to eighty-six other ongoing trials that are in need of volunteers at the moment."
Answered by AI
Does this study allow participation for individuals aged 80 years and above?
"In this clinical study, individuals aged between 18 and 45 are eligible to participate. There are separate trials available for those under 18 years of age (6 trials) and over 65 years of age (26 trials)."
Answered by AI
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