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

NCT03483805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Institut Polytechnique UniLaSalle

    collaborator UNKNOWN

  • Institut Pasteur de Lille

    collaborator OTHER

  • Association Française des Intolérants au Gluten (AFDIAG)

    collaborator UNKNOWN

  • Société Guaranteed Gluten Free (GGF)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-21
Primary Completion
2018-01-12
Completion
2018-01-12

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT03483805 on ClinicalTrials.gov