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

Primary Purpose

Celiac Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Protalsafe

Placebo

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring synbiotic, nutrition, permeability, gluten free diet, quality of life, digestive comfort

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Pasteur de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Protalsafe product, daily, 12 weeks

Placebo product, daily, 12 weeks

Outcomes

Primary Outcome Measures

Lactulose/mannitol recovery in 5-hour urine sample

ratio of the two sugars following ingestion

serum zonulin

circulating concentration

Secondary Outcome Measures

microbiota profile

taxonomic sequencing

digestive health

gastrointestinal symptoms rating scale (GSRS), 13 questions with answers rating from 0 to 3

digestive comfort

visual analogic scale on digestive symptoms, 5 questions with 10cm scale rating from no symptoms (left) to worsening

quality of life- digestive health

celiac disease quality of life questionnaire (F-CDQ), subset of digestive questions

quality of life

celiac disease quality of life questionnaire (F-CDQ)

circulating inflammation markers

concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10

Full Information

NCT ID

NCT03483805

First Posted

March 19, 2018

Last Updated

April 19, 2018

Sponsor

Société Guaranteed Gluten Free (GGF)

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03483805

Brief Title

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

Acronym

Protalsafe

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

December 21, 2016 (Actual)

Primary Completion Date

January 12, 2018 (Actual)

Study Completion Date

January 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société Guaranteed Gluten Free (GGF)

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease

Keywords

synbiotic, nutrition, permeability, gluten free diet, quality of life, digestive comfort

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Protalsafe product, daily, 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo product, daily, 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Protalsafe

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

maize maltodextrin in powder form, to be diluted in water

Primary Outcome Measure Information:

Title

Lactulose/mannitol recovery in 5-hour urine sample

Description

ratio of the two sugars following ingestion

Time Frame

after 12 weeks of treatment

Title

serum zonulin

Description

circulating concentration

Time Frame

after 12 weeks of treatment

Secondary Outcome Measure Information:

Title

microbiota profile

Description

taxonomic sequencing

Time Frame