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

NCT01469936 | Unknown

• 1 other identifier: 2010-A00971-38
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline.

  The Gastrointestinal Quality of Life Index is a validated questionnaire of 36 questions related to gastrointestinal pain and discomfort, including accelerated or stalled transit, assessing the impact of these symptoms on the quality of life.

  Day D0; Day D35 (+/-7)

Secondary Outcomes (9)

• Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline

  Day D0; 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.

  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.

  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.

  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.

  Day D0; Day D35 (+/-7); Day D49 (+/-7)

Study Arms (2)

PERMEAPROTECT

EXPERIMENTAL

Dietary Supplement: PERMEAPROTECT

PLACEBO

PLACEBO COMPARATOR

Dietary Supplement: PLACEBO

Interventions

PERMEAPROTECT 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

PERMEAPROTECT

PLACEBO DIETARY_SUPPLEMENT

Duration : 5 weeks +/- 1 week. Dosage: * First Week : 1/2 stick per day * Second to 5th Week : 1 stick per day

PLACEBO

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lescuyer Laboratory: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Unité de Recherche Clinique en Immunologie de Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Grégoire Cozon, MD

  Hospice Civils de Lyon, Lyon, France

  PRINCIPAL INVESTIGATOR

• Catherine Goujon, MD

  Hospices Civiles de Lyon, Lyon, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

FR (1)