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

Fibromyalgia Clinical Trial

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)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT01469936
• Study type: Interventional
• Source: Lescuyer Laboratory
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2011
• Completion date: December 2016