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Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients (Protalsafe)

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.
 
ClinicalTrials.gov Identifier: NCT03483805
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Institut Polytechnique UniLaSalle
Institut Pasteur de Lille
Association Française des Intolérants au Gluten (AFDIAG)
Information provided by (Responsible Party):
Société Guaranteed Gluten Free (GGF)

Brief Summary:
Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.

Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: Protalsafe Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Treatment
Protalsafe product, daily, 12 weeks
Dietary Supplement: Protalsafe
mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water

Placebo Comparator: Placebo
Placebo product, daily, 12 weeks
Dietary Supplement: Placebo
maize maltodextrin in powder form, to be diluted in water




Primary Outcome Measures :
  1. Lactulose/mannitol recovery in 5-hour urine sample [ Time Frame: after 12 weeks of treatment ]
    ratio of the two sugars following ingestion

  2. serum zonulin [ Time Frame: after 12 weeks of treatment ]
    circulating concentration


Secondary Outcome Measures :
  1. microbiota profile [ Time Frame: baseline and after 12 weeks of treatment ]
    taxonomic sequencing

  2. digestive health [ Time Frame: baseline and after 12 weeks of treatment ]
    gastrointestinal symptoms rating scale (GSRS), 13 questions with answers rating from 0 to 3

  3. digestive comfort [ Time Frame: baseline and after 12 weeks of treatment ]
    visual analogic scale on digestive symptoms, 5 questions with 10cm scale rating from no symptoms (left) to worsening

  4. quality of life- digestive health [ Time Frame: baseline and after 12 weeks of treatment ]
    celiac disease quality of life questionnaire (F-CDQ), subset of digestive questions

  5. quality of life [ Time Frame: baseline and after 12 weeks of treatment ]
    celiac disease quality of life questionnaire (F-CDQ)

  6. circulating inflammation markers [ Time Frame: baseline and after 12 weeks of treatment ]
    concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • celiac disease diagnosis at least 1 year ago
  • diagnosis proven through biopsy report or general practioner letter or health insurance cover
  • not following a strict gluten free diet (Pavie score 1-3)
  • covered by health insurance
  • not in exclusion period from another study

Exclusion Criteria:

  • pregnant, breastfeeding women or planing pregnancy
  • gluten intolerance of non celiac origin or any other dietary intolerance of allergy
  • digestive pathology other than celiac disease
  • chronic transit problems (diarrhoea or constipation)
  • uncontrolled pathology
  • diabetes
  • medical treatment impacting outcome markers (corticosteroids, NSAIDS, immune suppressor drugs, pancreatic enzymes, amphetamines)
  • recent or regular intake of prebiotics, probiotics, food supplements including B vitamins, iron or calcium.
  • antibiotics in the past month
  • excessive alcohol intake
  • drug user
  • planing to change tobacco use
  • any other reason why the investigator feels the subject may not be compliant
  • adults under judicial protection

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): NCT03483805


Locations
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France
Institut Pasteur de Lille
Lille, France
Sponsors and Collaborators
Société Guaranteed Gluten Free (GGF)
Institut Polytechnique UniLaSalle
Institut Pasteur de Lille
Association Française des Intolérants au Gluten (AFDIAG)

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Responsible Party: Société Guaranteed Gluten Free (GGF)
ClinicalTrials.gov Identifier: NCT03483805    
Other Study ID Numbers: 2016-A00330-51
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Société Guaranteed Gluten Free (GGF):
synbiotic
nutrition
permeability
gluten free diet
quality of life
digestive comfort
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases