EndometriosisNCT04091191
Evaluation of a Nutraceutical for Endometriosis Pain Relief
A study testing Meta19.01 in people with Endometriosis, run by Metagenics Europe at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Meta19.01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Oct 2021to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Endometriosis
- Being tested
- Meta19.01
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta19.01Dietary supplement
A specialized nutraceutical containing plant extracts, vitamins and fish oil
| Study group | Role | What they receive |
|---|---|---|
| Specialized nutraceutical | Active comparator | Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner. Receives: Dietary Supplement: Meta19.01 |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Meta19.01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start13 Oct 2021
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaacoub Salame, MD, Principal investigator, CHU Ambroise Paré de Mons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091191
- Sponsor's protocol ID
- Meta19.01
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2019
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of a Specialized Nutraceutical for Endometriosis
- ClinicalTrials.gov ID
- NCT04091191
- Acronym / sponsor ID
- Meta19.01
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Metagenics EuropeIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized nutraceutical | Active comparator | Dietary Supplement: Meta19.01Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner. |
| Placebo | Placebo comparator | Dietary Supplement: Meta19.01Identical 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta19.01A specialized nutraceutical containing plant extracts, vitamins and fish oil | Dietary supplement | Placebo, Specialized nutraceutical |
Primary outcome
Pain relief
Time frame: 3 months
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 secondary outcomes
Inflammation marker C-reactive protein (CRP)
Time frame: 3 months
General well-being
Time frame: 3 months
The need for analgesics
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaacoub Salame, MD principal investigator
CHU Ambroise Paré de Mons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta19.01 in people with Endometriosis, run by Metagenics Europe at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.