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

NCT ID: NCT03483805

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-21
• Study Completion Date: 2018-01-12

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.

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Protalsafe product, daily, 12 weeks

Group Type: EXPERIMENTAL

Protalsafe

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo product, daily, 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

maize maltodextrin in powder form, to be diluted in water

Interventions

Protalsafe

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

maize maltodextrin in powder form, to be diluted in water

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Polytechnique UniLaSalle

UNKNOWN

Sponsor Role: collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role: collaborator

Association Française des Intolérants au Gluten (AFDIAG)

UNKNOWN

Sponsor Role: collaborator

Société Guaranteed Gluten Free (GGF)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Pasteur de Lille

Lille, , France

Countries

France

Other Identifiers

2016-A00330-51

Identifier Type: -

Identifier Source: org_study_id