FibromyalgiaL2009-03NCT01469936

Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia

A study testing PERMEAPROTECT in people with Fibromyalgia, run by Lescuyer Laboratory at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Fibromyalgia is a medical disorder characterized by chronic widespread pain, and a heightened and painful response to pressure. Fibromyalgia symptoms are not restricted to pain, leading to the use of the alternative term fibromyalgia syndrome for the condition. Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Fibromyalgia
What is being tested?: PERMEAPROTECT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteFrance
Study dates: Nov 2011to Dec 2016
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 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

BMI between 18.5 and 30 kg/m²
Diagnosed fibromyalgia, according to the American College of Rheumatology criteria
Functional bowel discomfort or pain
Pre-menopausal woman with active contraception or post-menopausal woman

Who cannot join

Allergy to one (or more) component(s) of verum or placebo.
Disease or disease treatment that could interfere with the efficacy evaluation.
Treatment with statin (or HMG-CoA reductase inhibitors) associated with adverse effect
Treatment with Coumadin (or any other Vitamin K antagonists)
Severe depression (Beck Depression Inventory score > 16)
Recent (during the previous month) change(s) in probiotic intake (including fermented milk, kefir, ...)
History of major gastrointestinal surgery or inflammatory bowel disease
Pregnant, breastfeeding or intention of pregnancy in the next three month

Trial locations and contacts

1 site in 1 country.

France1 site

Unité de Recherche Clinique en Immunologie de Lyon Sud
Pierre-Bénite, 69495

Other trials in France

About this study

Official title: Study of the Effect of the Food Supplement PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia (a Pilot, Double-blind, Randomized, Placebo-controlled Study)

The origin of these symptoms is not yet known, and a few hypotheses have been stated. One of the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic, low-grade, intestinal inflammation due to an increased intestinal permeability.

In this study, we hypothesise that the food supplement PERMEAPROTECT (that contains, amongst other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability and low-grade inflammation, thus improving gastrointestinal quality of life.

Read the detailed description

Patients diagnosed with fibromyalgia will enter the study and follow a run-in phase during which they will all be supplemented with prebiotics, probiotics and grape fruit seed extract for 5 weeks :

Patients that do not present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will enter the randomised phase after 2 weeks +/- 1 week, at day D0.
Patients that do present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will exit the study at that point, and follow their usual medical care.

Patients that enter the randomised phase will be supplemented with either PERMEAPROTECT or a PLACEBO, for 5 weeks +/- 1 week. Patients will then follow a 2 weeks +/- 1 week of wash-out, during which no supplementation will be made.

Measures of the outcomes will be made :

at Day 0 (beginning of supplementation).
at Day 35 (+/- 7) (end of supplementation).
at Day 49 (+/- 7) (end of follow-up, end of study)

Conditions: Fibromyalgia
Being tested: PERMEAPROTECT, PLACEBO
Keywords: Fibromyalgia, Irritable Bowel Syndrome
Medical subject headings: Fibromyalgia, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PERMEAPROTECTDietary supplement
Composition : glutamine, curcuma, zinc, chitosan, beta carotene, Green Tea polyphenols, thiamine and folic acid.
Duration : 5 weeks +/- 1 week.
Dosage :
- First Week of intervention : 1/2 stick per day
- Second to 5th Week : 1 stick per day
PLACEBODietary supplement
Duration : 5 weeks +/- 1 week.
Dosage:
- First Week : 1/2 stick per day
- Second to 5th Week : 1 stick per day

Study groups in NCT01469936
Study group	Role	What they receive
PERMEAPROTECT	Experimental	Not described Receives: Dietary Supplement: PERMEAPROTECT
PLACEBO	Placebo comparator	Not described Receives: Dietary Supplement: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline.
The Gastrointestinal Quality of Life Index is a validated questionnaire of 36 questions related to gastrointestinal pain and discomfort, including accelerated or stalled transit, assessing the impact of these symptoms on the quality of life.
Measured: Day D0; Day D35 (+/-7)

Secondary outcomes (9)

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline
The Gastrointestinal Quality of Life Index is a validated questionnaire of 36 questions related to gastrointestinal pain and discomfort, including accelerated or stalled transit, assessing the impact of these symptoms on the quality of life.
Measured: Day D0; Day D49 (+/-7)
Improvement of the Impact of Fibromyalgia on the Quality of life, measured by the Fibromyalgia Impact Questionnaire (FIQ), at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
The FIQ is a validated questionnaire measuring the specific impact of Fibromyalgia on the quality of life.
Measured: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Improvement of the subjective evaluation, by the patient, of the intensity of gastrointestinal symptoms, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Measured on a 100mm scale
Measured: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Improvement of the subjective evaluation, by the patient, of the satisfactory relief of gastrointestinal symptoms, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Measured by a binary response (yes/no)
Measured: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Improvement of the subjective evaluation, by the patient, of the satisfactory relief of gastrointestinal pain, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Measured by a binary response (yes/no)
Measured: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Reduction of the serum C-reactive Protein (usCRP), measured by the ultra-sensitive method, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Measured: Day D0; Day D35 (+/-7);
Reduction of the intestinal permeability, measured by the urinary ratio of lactulose/mannitol, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
The intestinal permeability is measured by the ratio of lactulose/mannitol. A solution of lactulose and mannitol is absorbed by the patient. Total urines are collected during the next 5 hours. Urinary lactulose and mannitol concentrations are determined and the ratio calculated.
Measured: Day D0; Day D35 (+/-7)
Reduction of blood oxidative stress markers (reduced glutathione, oxidized glutathione and malondialdehyde), at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Measured: Day D0; Day D35 (+/-7)
Improvement of the general Quality of Life, measured by the Medical Outcome Study Short Form (MOS SF-36), at the end of the supplementation period (5 weeks), and at the en of follow-up (2 weeks), compared with baseline
Validated questionnaire measuring the impact of health status on the quality of life.
Measured: Day D0; Day D35 (+/-7); Day D49 (+/-7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Dec 2016

First posted10 Nov 2011 (estimated)
Study startNov 2011
Primary completionFeb 2016
Study completionDec 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FibromyalgiaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01469936
Sponsor's protocol ID: 2010-A00971-38
Acronym: L2009-03
Status last verified: Sep 2016
First submitted: 28 Oct 2011
Last updated: 7 Sep 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Effect of the Food Supplement PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia (a Pilot, Double-blind, Randomized, Placebo-controlled Study)
ClinicalTrials.gov ID: NCT01469936
Acronym / sponsor ID: L2009-03 / 2010-A00971-38
Conditions: Fibromyalgia
Keywords: Fibromyalgia, Irritable Bowel Syndrome
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (actual)
Lead sponsor: Lescuyer LaboratoryIndustry (pharma, biotech, devices)
Collaborators: Hospices Civils de Lyon
Study start: Nov 2011
Primary completion: Feb 2016 (actual)
Study completion: Dec 2016 (estimated)
First posted: 10 Nov 2011 (estimated)
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.

Detailed description

Patients diagnosed with fibromyalgia will enter the study and follow a run-in phase during which they will all be supplemented with prebiotics, probiotics and grape fruit seed extract for 5 weeks :

Patients that do not present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will enter the randomised phase after 2 weeks +/- 1 week, at day D0.
Patients that do present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will exit the study at that point, and follow their usual medical care.

Measures of the outcomes will be made :

at Day 0 (beginning of supplementation).
at Day 35 (+/- 7) (end of supplementation).
at Day 49 (+/- 7) (end of follow-up, end of study)

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PERMEAPROTECT	Experimental	Dietary Supplement: PERMEAPROTECT
PLACEBO	Placebo comparator	Dietary Supplement: PLACEBO

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

BMI between 18.5 and 30 kg/m²
Diagnosed fibromyalgia, according to the American College of Rheumatology criteria
Functional bowel discomfort or pain
Pre-menopausal woman with active contraception or post-menopausal woman

Key exclusion criteria (8 listed)

Allergy to one (or more) component(s) of verum or placebo.
Disease or disease treatment that could interfere with the efficacy evaluation.
Treatment with statin (or HMG-CoA reductase inhibitors) associated with adverse effect
Treatment with Coumadin (or any other Vitamin K antagonists)
Severe depression (Beck Depression Inventory score > 16)

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
PERMEAPROTECTComposition : glutamine, curcuma, zinc, chitosan, beta carotene, Green Tea polyphenols, thiamine and folic acid. Duration : 5 weeks +/- 1 week. Dosage : * First Week of intervention : 1/2 stick per day * Second to 5th Week : 1 stick per day	Dietary supplement	PERMEAPROTECT
PLACEBODuration : 5 weeks +/- 1 week. Dosage: * First Week : 1/2 stick per day * Second to 5th Week : 1 stick per day	Dietary supplement	PLACEBO

Primary outcome

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7)
The Gastrointestinal Quality of Life Index is a validated questionnaire of 36 questions related to gastrointestinal pain and discomfort, including accelerated or stalled transit, assessing the impact of these symptoms on the quality of life.

9 secondary outcomes

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline
Time frame: Day D0; Day D49 (+/-7)
Improvement of the Impact of Fibromyalgia on the Quality of life, measured by the Fibromyalgia Impact Questionnaire (FIQ), at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Improvement of the subjective evaluation, by the patient, of the intensity of gastrointestinal symptoms, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Improvement of the subjective evaluation, by the patient, of the satisfactory relief of gastrointestinal symptoms, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Improvement of the subjective evaluation, by the patient, of the satisfactory relief of gastrointestinal pain, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Reduction of the serum C-reactive Protein (usCRP), measured by the ultra-sensitive method, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7);
Reduction of the intestinal permeability, measured by the urinary ratio of lactulose/mannitol, at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7)
Reduction of blood oxidative stress markers (reduced glutathione, oxidized glutathione and malondialdehyde), at the end of the supplementation period (5 weeks), and at end of follow-up (2 weeks), compared with baseline.
Time frame: Day D0; Day D35 (+/-7)
Improvement of the general Quality of Life, measured by the Medical Outcome Study Short Form (MOS SF-36), at the end of the supplementation period (5 weeks), and at the en of follow-up (2 weeks), compared with baseline
Time frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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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.

Grégoire Cozon, MD principal investigator

Hospice Civils de Lyon, Lyon, France

Catherine Goujon, MD study director

Hospices Civiles de Lyon, Lyon, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PERMEAPROTECT in people with Fibromyalgia, run by Lescuyer Laboratory at 1 site in France.

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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. 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 France. 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?

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?

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline. (time frame: Day D0; Day D35 (+/-7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01469936.

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 7 Sep 2016.