Clinical trial NCT01469936: Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Irritable Bowel Syndrome
Lead sponsor: Lescuyer Laboratory
Sponsor class: INDUSTRY
Collaborators: name: Hospices Civils de Lyon
First posted: 2011-11-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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 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

Primary outcomes:
measure: Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline.
timeFrame: Day D0; Day D35 (+/-7)
Secondary outcomes:
measure: Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline
timeFrame: Day D0; Day D49 (+/-7)
measure: 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.
timeFrame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
measure: 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.
timeFrame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
measure: 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.
timeFrame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
measure: 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.
timeFrame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
measure: 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.
timeFrame: Day D0; Day D35 (+/-7);
measure: 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.
timeFrame: Day D0; Day D35 (+/-7)
measure: 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.
timeFrame: Day D0; Day D35 (+/-7)
measure: 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
timeFrame: Day D0; Day D35 (+/-7); Day D49 (+/-7)
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Unité de Recherche Clinique en Immunologie de Lyon Sud
Study officials:
affiliation: Hospice Civils de Lyon, Lyon, France
name: Grégoire Cozon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civiles de Lyon, Lyon, France
name: Catherine Goujon, MD
role: STUDY_DIRECTOR
References: