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

NCT01469936 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    collaborator OTHER

  • Lescuyer Laboratory

    lead INDUSTRY

Principal Investigators

  • Grégoire Cozon, MD · Hospice Civils de Lyon, Lyon, France

  • Catherine Goujon, MD · Hospices Civiles de Lyon, Lyon, France

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-02-29
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01469936 on ClinicalTrials.gov