Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia - Full Text View

Purpose

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. Other symptoms include functional gastrointestinal pain and discomfort.

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.

Condition	Intervention
Fibromyalgia	Dietary Supplement: PERMEAPROTECT Dietary Supplement: PLACEBO

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
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)

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Fibromyalgia

U.S. FDA Resources

Further study details as provided by Lescuyer Laboratory:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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.
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) ] [ Designated as safety issue: Yes ]
The FIQ is a validated questionnaire measuring the specific impact of Fibromyalgia on the quality of life.
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) ] [ Designated as safety issue: No ]
Measured on a 100mm scale
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) ] [ Designated as safety issue: No ]
Measured by a binary response (yes/no)
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) ] [ Designated as safety issue: No ]
Measured by a binary response (yes/no)
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); Day D49 (+/-7) ] [ Designated as safety issue: No ]
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); Day D49 (+/-7) ] [ Designated as safety issue: No ]
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.
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); Day D49 (+/-7) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Validated questionnaire measuring the impact of health status on the quality of life.

Estimated Enrollment:	40
Study Start Date:	November 2011
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PERMEAPROTECT	Dietary Supplement: PERMEAPROTECT 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
Placebo Comparator: PLACEBO	Dietary Supplement: PLACEBO Duration : 5 weeks +/- 1 week. Dosage: First Week : 1/2 stick per day Second to 5th Week : 1 stick per day

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)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469936

Contacts

Contact: Grégoire Cozon, MD	+33 472 11 74 59	gregoire.cozon@chu-lyon.fr
Contact: Emmanuel Barrat, PhD	+33 546 56 30 48	emmanuel.barrat@laboratoire-lescuyer.com

Locations

France
Unité de Recherche Clinique en Immunologie de Lyon Sud	Recruiting
Pierre-Bénite, France, 69495
Contact: Grégoire Cozon, MD +33 472 11 74 59 gregoire.cozon@chu-lyon.fr
Contact: Sophie Grande, MD +33 478 86 41 25 sophie.grande@chu-lyon.fr
Principal Investigator: Sophie Grande, MD

Sponsors and Collaborators

Lescuyer Laboratory

Hospices Civils de Lyon

Investigators

Principal Investigator:	Grégoire Cozon, MD	Hospice Civils de Lyon, Lyon, France
Study Director:	Catherine Goujon, MD	Hospices Civiles de Lyon, Lyon, France

More Information

No publications provided

Responsible Party:	Lescuyer Laboratory
ClinicalTrials.gov Identifier:	NCT01469936 History of Changes
Other Study ID Numbers:	2010-A00971-38
Study First Received:	October 28, 2011
Last Updated:	January 10, 2013
Health Authority:	France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lescuyer Laboratory:

Fibromyalgia
Irritable Bowel Syndrome

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia (L2009-03)