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

September 6, 2016 updated by: Lescuyer Laboratory

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 :

  • 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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Unité de Recherche Clinique en Immunologie de Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Dietary supplement: PLACEBO

Duration : 5 weeks +/- 1 week.

Dosage:

  • First Week : 1/2 stick per day
  • Second to 5th Week : 1 stick per day
Experimental: PERMEAPROTECT
Dietary supplement: PERMEAPROTECT

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 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)
The FIQ is a validated questionnaire measuring the specific impact of Fibromyalgia on the quality of life.
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)
Measured on a 100mm scale
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)
Measured by a binary response (yes/no)
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)
Measured by a binary response (yes/no)
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 D0; Day D35 (+/-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)
The intestinal permeability is measured by the ratio of lactulose/mannitol. A solution of lactulose and mannitol is absorbed by the patient. Total urines are collected during the next 5 hours. Urinary lactulose and mannitol concentrations are determined and the ratio calculated.
Day D0; Day D35 (+/-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 D0; Day D35 (+/-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)
Validated questionnaire measuring the impact of health status on the quality of life.
Day D0; Day D35 (+/-7); Day D49 (+/-7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lescuyer Laboratory

Collaborators

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Grégoire Cozon, MD, Hospice Civils de Lyon, Lyon, France
  • Study Director: Catherine Goujon, MD, Hospices Civiles de Lyon, Lyon, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00971-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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