Status:
UNKNOWN
Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia
Lead Sponsor:
Lescuyer Laboratory
Collaborating Sponsors:
Hospices Civils de Lyon
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 ...
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 : *...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01469936
Start Date
November 1 2011
End Date
December 1 2016
Last Update
September 7 2016
Active Locations (1)
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1
Unité de Recherche Clinique en Immunologie de Lyon Sud
Pierre-Bénite, France, 69495