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)

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



Sponsors

Lead Sponsor


Collaborators



Source

Lescuyer Laboratory

Oversight Info

Authority

France: Committee for the Protection of Personnes

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)


Has Dmc

No


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)

Overall Status

Recruiting

Start Date

2011-11-01

Completion Date

2014-11-01

Primary Completion Date

2014-04-01

Phase

N/A

Study Type

Interventional

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary Outcome

Measure

Time Frame

Safety Issue

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at the end of the supplementation period (5 weeks), compared with baseline.
Day D0; Day D35 (+/-7)
No

Secondary Outcome

Measure

Time Frame

Safety Issue

Improvement of the Gastrointestinal Quality of Life Index (GIQLI) at end of follow-up (2 weeks), compared with baseline
Day D0; Day D49 (+/-7)
No
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
Yes
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
No
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
No
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.
Day D0; Day D35 (+/-7); Day D49 (+/-7)
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
Day D0; Day D35 (+/-7); Day D49 (+/-7)
No

Enrollment

40

Condition


Intervention

Intervention Type

Dietary Supplement

Intervention Name


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

Arm Group Label

PERMEAPROTECT


Intervention Type

Dietary Supplement

Intervention Name


Description

Duration : 5 weeks +/- 1 week.
Dosage:
First Week : 1/2 stick per day
Second to 5th Week : 1 stick per day

Arm Group Label

PLACEBO



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

Gender

Female

Minimum Age

18 Years

Maximum Age

60 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

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

Overall Contact

Last Name

Grégoire Cozon, MD

Phone

+33 472 11 74 59

Email

gregoire.cozon@chu-lyon.fr


Location

Facility

Status

Contact

Investigator

Unité de Recherche Clinique en Immunologie de Lyon Sud
Pierre-Bénite 69495 France
Recruiting
Last Name: Grégoire Cozon, MD
Phone: +33 472 11 74 59
Email: gregoire.cozon@chu-lyon.fr
Last Name: Sophie Grande, MD
Role: Principal Investigator

Location Countries

Country

France


Verification Date

2013-01-01

Lastchanged Date

2013-01-10

Firstreceived Date

2011-10-28

Responsible Party

Responsible Party Type

Sponsor


Keywords


Is Fda Regulated

No

Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

PERMEAPROTECT

Arm Group Type

Experimental


Arm Group Label

PLACEBO

Arm Group Type

Placebo Comparator



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Emmanuel Barrat, PhD

Phone

+33 546 56 30 48

Email

emmanuel.barrat@laboratoire-lescuyer.com


Acronym

L2009-03


Information obtained from ClinicalTrials.gov on January 22, 2013

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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