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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01469936
First Posted: November 10, 2011
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Lescuyer Laboratory
  Purpose

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.


Condition Intervention
Fibromyalgia Dietary Supplement: PERMEAPROTECT Dietary Supplement: PLACEBO

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


Further study details as provided by Lescuyer Laboratory:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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

  • 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)

  • 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)

  • 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); ]
  • 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.

  • 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) ]
  • 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.


Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469936


Locations
France
Unité de Recherche Clinique en Immunologie de Lyon Sud
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Lescuyer Laboratory
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
  More Information

Responsible Party: Lescuyer Laboratory
ClinicalTrials.gov Identifier: NCT01469936     History of Changes
Other Study ID Numbers: 2010-A00971-38
First Submitted: October 28, 2011
First Posted: November 10, 2011
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Lescuyer Laboratory:
Fibromyalgia
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases