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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)

Tracking Information
First Submitted Date  ICMJE March 19, 2018
First Posted Date  ICMJE March 30, 2018
Last Update Posted Date April 20, 2018
Actual Study Start Date  ICMJE December 21, 2016
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • Lactulose/mannitol recovery in 5-hour urine sample [ Time Frame: after 12 weeks of treatment ]
    ratio of the two sugars following ingestion
  • serum zonulin [ Time Frame: after 12 weeks of treatment ]
    circulating concentration
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
  • Lactulose/mannitol recovery in 5-hour urine sample [ Time Frame: baseline and after 12 weeks of treatment ]
    ratio of the two sugars following ingestion
  • serum zonulin [ Time Frame: baseline and after 12 weeks of treatment ]
    circulating concentration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • microbiota profile [ Time Frame: baseline and after 12 weeks of treatment ]
    taxonomic sequencing
  • 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
  • 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
  • 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
  • quality of life [ Time Frame: baseline and after 12 weeks of treatment ]
    celiac disease quality of life questionnaire (F-CDQ)
  • circulating inflammation markers [ Time Frame: baseline and after 12 weeks of treatment ]
    concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
  • microbiota profile [ Time Frame: baseline and after 12 weeks of treatment ]
    taxonomic sequencing
  • digestive health [ Time Frame: baseline and after 12 weeks of treatment ]
    gastrointestinal symptoms rating scale (GSRS)
  • digestive comfort [ Time Frame: baseline and after 12 weeks of treatment ]
    visual analogic scale on digestive symptoms
  • 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
  • quality of life [ Time Frame: baseline and after 12 weeks of treatment ]
    celiac disease quality of life questionnaire (F-CDQ)
  • circulating inflammation markers [ Time Frame: baseline and after 12 weeks of treatment ]
    concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
Official Title  ICMJE Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Dietary Supplement: Protalsafe
    mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water
  • Dietary Supplement: Placebo
    maize maltodextrin in powder form, to be diluted in water
Study Arms  ICMJE
  • Experimental: Treatment
    Protalsafe product, daily, 12 weeks
    Intervention: Dietary Supplement: Protalsafe
  • Placebo Comparator: Placebo
    Placebo product, daily, 12 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2018)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 12, 2018
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03483805
Other Study ID Numbers  ICMJE 2016-A00330-51
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Société Guaranteed Gluten Free (GGF)
Study Sponsor  ICMJE Société Guaranteed Gluten Free (GGF)
Collaborators  ICMJE
  • Institut Polytechnique UniLaSalle
  • Institut Pasteur de Lille
  • Association Française des Intolérants au Gluten (AFDIAG)
Investigators  ICMJE Not Provided
PRS Account Société Guaranteed Gluten Free (GGF)
Verification Date April 2018

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