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

Launched by LESCUYER LABORATORY · Nov 8, 2011

Keywords

ClinConnect Summary

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 randomis...

Gender

FEMALE

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