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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Lescuyer Laboratory
Sponsor:
Collaborator:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Lescuyer Laboratory
ClinicalTrials.gov Identifier:
NCT01469936
First received: October 28, 2011
Last updated: March 17, 2014
Last verified: March 2014

October 28, 2011
March 17, 2014
November 2011
April 2015   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01469936 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    Validated questionnaire measuring the impact of health status on the quality of life.
  • 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) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day D0; Day D35 (+/-7); Day D49 (+/-7) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    Validated questionnaire measuring the impact of health status on the quality of life.
Not Provided
Not Provided
 
Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia
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.

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)
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Fibromyalgia
  • 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
  • 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
    Intervention: Dietary Supplement: PERMEAPROTECT
  • Placebo Comparator: PLACEBO
    Intervention: Dietary Supplement: PLACEBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2015
April 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact: Grégoire Cozon, MD +33 472 11 74 59 gregoire.cozon@chu-lyon.fr
Contact: Emmanuel Barrat, PhD +33 546 56 30 48 emmanuel.barrat@laboratoire-lescuyer.com
France
 
NCT01469936
2010-A00971-38
No
Lescuyer Laboratory
Lescuyer Laboratory
Hospices Civils de Lyon
Principal Investigator: Grégoire Cozon, MD Hospice Civils de Lyon, Lyon, France
Study Director: Catherine Goujon, MD Hospices Civiles de Lyon, Lyon, France
Lescuyer Laboratory
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP