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

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PERMEAPROTECT
PLACEBO
Sponsored by
Lescuyer Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Unité de Recherche Clinique en Immunologie de Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PERMEAPROTECT

PLACEBO

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 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.
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.
The FIQ is a validated questionnaire measuring the specific impact of Fibromyalgia on the quality of life.
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.
Measured on a 100mm scale
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.
Measured by a binary response (yes/no)
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.
Measured by a binary response (yes/no)
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.
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.
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.
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.
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
Validated questionnaire measuring the impact of health status on the quality of life.

Full Information

First Posted
October 28, 2011
Last Updated
September 6, 2016
Sponsor
Lescuyer Laboratory
Collaborators
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01469936
Brief Title
Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia
Acronym
L2009-03
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lescuyer Laboratory
Collaborators
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PERMEAPROTECT
Arm Type
Experimental
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
PERMEAPROTECT
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
Duration : 5 weeks +/- 1 week. Dosage: First Week : 1/2 stick per day Second to 5th Week : 1 stick per day
Primary Outcome Measure Information:
Title
Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline.
Description
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.
Time Frame
Day D0; Day D35 (+/-7)
Secondary Outcome Measure Information:
Title
Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline
Description
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.
Time Frame
Day D0; Day D49 (+/-7)
Title
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.
Description
The FIQ is a validated questionnaire measuring the specific impact of Fibromyalgia on the quality of life.
Time Frame
Day D0; Day D35 (+/-7); Day D49 (+/-7)
Title
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.
Description
Measured on a 100mm scale
Time Frame
Day D0; Day D35 (+/-7); Day D49 (+/-7)
Title
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.
Description
Measured by a binary response (yes/no)
Time Frame
Day D0; Day D35 (+/-7); Day D49 (+/-7)
Title
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.
Description
Measured by a binary response (yes/no)
Time Frame
Day D0; Day D35 (+/-7); Day D49 (+/-7)
Title
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);
Title
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.
Description
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.
Time Frame
Day D0; Day D35 (+/-7)
Title
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)
Title
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
Description
Validated questionnaire measuring the impact of health status on the quality of life.
Time Frame
Day D0; Day D35 (+/-7); Day D49 (+/-7)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grégoire Cozon, MD
Organizational Affiliation
Hospice Civils de Lyon, Lyon, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Goujon, MD
Organizational Affiliation
Hospices Civiles de Lyon, Lyon, France
Official's Role
Study Director
Facility Information:
Facility Name
Unité de Recherche Clinique en Immunologie de Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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

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