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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT01469936
• Date of registration: 28/10/2011
• Primary sponsor: Lescuyer Laboratory
• Public title: Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia L2009-03
• Scientific 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)
• Date of first enrolment: November 2011
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01469936
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Countries of recruitment

France

Contacts

• Name: Grégoire Cozon, MD

• Name: Grégoire Cozon, MD

• Name: Grégoire Cozon, MD
• Affiliation: Hospice Civils de Lyon, Lyon, France

• Name: Catherine Goujon, MD
• Affiliation: Hospices Civiles de Lyon, Lyon, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Fibromyalgia

Intervention(s)

Dietary Supplement: PERMEAPROTECT

Dietary Supplement: PLACEBO

Primary Outcome(s)

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline. [Time Frame: Day D0; Day D35 (+/-7)]

Secondary Outcome(s)

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline [Time Frame: Day D0; Day D49 (+/-7)]

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 [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

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. [Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7)]

Secondary ID(s)

2010-A00971-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospices Civils de Lyon