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

NCT ID: NCT01469936

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-12-31

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)

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

PERMEAPROTECT

Group Type: EXPERIMENTAL

PERMEAPROTECT

Intervention Type: DIETARY_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

PLACEBO

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DIETARY_SUPPLEMENT

Duration : 5 weeks +/- 1 week.

Dosage:

• First Week : 1/2 stick per day
• Second to 5th Week : 1 stick per day

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO

Duration : 5 weeks +/- 1 week.

Dosage:

• First Week : 1/2 stick per day
• Second to 5th Week : 1 stick per day

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Lescuyer Laboratory

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grégoire Cozon, MD

Role: PRINCIPAL_INVESTIGATOR

Hospice Civils de Lyon, Lyon, France

Catherine Goujon, MD

Role: STUDY_DIRECTOR

Hospices Civiles de Lyon, Lyon, France

Locations

Unité de Recherche Clinique en Immunologie de Lyon Sud

Pierre-Bénite, , France

Countries

France

Other Identifiers

2010-A00971-38

Identifier Type: -

Identifier Source: org_study_id