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OpenTrials
Completed

NCT Number: NCT03483805

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

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Pasteur de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protalsafe

Dietary Supplement

mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water

Placebo

Dietary Supplement

maize maltodextrin in powder form, to be diluted in water

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Société Guaranteed Gluten Free (GGF)

Industry

Collaborators

  • Association Française des Intolérants au Gluten (AFDIAG)
  • Institut Pasteur de Lille
  • Institut Polytechnique UniLaSalle

Registry information

Official study title

Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

Acronym: Protalsafe

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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