Evaluation of a Nutraceutical for Endometriosis Pain Relief

A Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of a Specialized Nutraceutical for Endometriosis

Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Dietary supplement: Meta19.01

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hainout
    • Mons, Hainout, Belgium, 7000
      • CHU Ambroise Paré de Mons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Confirmed endometriosis and/or Positive NMR
• 18-49y
• Mean pain score >6 on the assessment of pelvic pain (Visual analogue scale)
• Not eligible for surgery in the coming 3 months or had surgery >3 months before inclusion in the study
• >3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
• Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

• Planned surgery during study
• <3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
• Chronic inflammatory disease (Chron's disease, Rheumatism,..)
• Pregnancy
• Bariatric surgery
• Malabsorption issues
• Allergy or hypersensitivity to the study product:
• Fish and products thereof: fish oil
• Soybeans and products thereof
• Alcohol or substance abuse
• Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
• Intake of other food supplements, including omega 3 and omega 6
• Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Specialized nutraceutical; Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.	Dietary supplement: Meta19.01; A specialized nutraceutical containing plant extracts, vitamins and fish oil
Placebo Comparator: Placebo; Identical placebo formulated without active ingredients in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.	Dietary supplement: Meta19.01; A specialized nutraceutical containing plant extracts, vitamins and fish oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	pain relief monitored via the Assessment of Pelvic Pain (Visual Analogue scale, VAS) in the Endometriosis Health Profile 30 questions (EHP-30) at baseline and after 3 months of study product intake. The mean of all 3 VAS scales is taken to monitor the evolution of the pain of the subjects. Scores can be given from 0 to 10 with 0 as no pain and 10 as unbearable pain.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation marker C-reactive protein (CRP)	CRP will be measured at baseline and after 3 months of study product intake. High CRP values (>3mg/L) indicate inflammation while low CRP values (<1 mg/L) indicate no inflammation.	3 months
General well-being	The general well-being will be monitored via the Endometriosis Health Profile questionnaire with 30 questions (EHP-30) at baseline and after 3 months of product intake. These scales are transformed into a score from 0 to 100, in which 0 indicates a better health status, while 100 indicates a worse quality of life.	3 months
The need for analgesics	The need for analgesics while taking the study product will be monitored via an analgesic diary completed every time the subject takes pain medication. Over 3 months, the total need for analgesics per month will be counted and compared inbetween both groups.	3 months

Collaborators and Investigators

• Sponsor: Metagenics Europe
• Investigators: Principal Investigator: Yaacoub Salame, MD, CHU Ambroise Paré de Mons

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: Meta19.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No