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

Study Overview
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Brief Summary
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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.

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

Conditions
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Celiac Disease

Intervention / Treatment
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* Dietary Supplement: Protalsafe
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Protalsafe product, daily, 12 weeks | Dietary Supplement: Protalsafe<br>* mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water<br>|
| Placebo Comparator: Placebo<br>Placebo product, daily, 12 weeks | Dietary Supplement: Placebo<br>* maize maltodextrin in powder form, to be diluted in water<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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permeability, gluten free diet, quality of life, digestive comfort, synbiotic, nutrition