Clinical trial NCT03483805: Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: synbiotic
nutrition
permeability
gluten free diet
quality of life
digestive comfort
Lead sponsor: Société Guaranteed Gluten Free (GGF)
Sponsor class: INDUSTRY
Collaborators: name: Institut Polytechnique UniLaSalle
name: Institut Pasteur de Lille
name: Association Française des Intolérants au Gluten (AFDIAG)
First posted: 2018-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Lactulose/mannitol recovery in 5-hour urine sample
timeFrame: after 12 weeks of treatment
measure: serum zonulin
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: microbiota profile
timeFrame: baseline and after 12 weeks of treatment
measure: digestive health
timeFrame: baseline and after 12 weeks of treatment
measure: digestive comfort
timeFrame: baseline and after 12 weeks of treatment
measure: quality of life- digestive health
timeFrame: baseline and after 12 weeks of treatment
measure: quality of life
timeFrame: baseline and after 12 weeks of treatment
measure: circulating inflammation markers
timeFrame: baseline and after 12 weeks of treatment
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut Pasteur de Lille
Study officials:
References: