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

Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New 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.

Study Overview

• Status: Completed
• Conditions: Celiac Disease
• Intervention / Treatment: Dietary supplement: Protalsafe; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Institut Pasteur de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Protalsafe product, daily, 12 weeks	Dietary supplement: Protalsafe; mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water
Placebo Comparator: Placebo; Placebo product, daily, 12 weeks	Dietary supplement: Placebo; maize maltodextrin in powder form, to be diluted in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactulose/mannitol recovery in 5-hour urine sample	ratio of the two sugars following ingestion	after 12 weeks of treatment
serum zonulin	circulating concentration	after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiota profile	taxonomic sequencing	baseline and after 12 weeks of treatment
digestive health	gastrointestinal symptoms rating scale (GSRS), 13 questions with answers rating from 0 to 3	baseline and after 12 weeks of treatment
digestive comfort	visual analogic scale on digestive symptoms, 5 questions with 10cm scale rating from no symptoms (left) to worsening	baseline and after 12 weeks of treatment
quality of life- digestive health	celiac disease quality of life questionnaire (F-CDQ), subset of digestive questions	baseline and after 12 weeks of treatment
quality of life	celiac disease quality of life questionnaire (F-CDQ)	baseline and after 12 weeks of treatment
circulating inflammation markers	concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10	baseline and after 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Société Guaranteed Gluten Free (GGF)
• Collaborators: Institut Pasteur de Lille; Institut Polytechnique UniLaSalle; Association Française des Intolérants au Gluten (AFDIAG)

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2016
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; nutrition; synbiotic; permeability; gluten free diet; digestive comfort
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 2016-A00330-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No