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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water
maize maltodextrin in powder form, to be diluted in water
Institut Pasteur de Lille
Lille, France
Lactulose/mannitol recovery in 5-hour urine sample
ratio of the two sugars following ingestion
Time frame: after 12 weeks of treatment
serum zonulin
circulating concentration
Time frame: after 12 weeks of treatment
microbiota profile
taxonomic sequencing
Time frame: baseline and after 12 weeks of treatment
digestive health
gastrointestinal symptoms rating scale (GSRS), 13 questions with answers rating from 0 to 3
Time frame: 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
Time frame: baseline and after 12 weeks of treatment
quality of life- digestive health
celiac disease quality of life questionnaire (F-CDQ), subset of digestive questions
Time frame: baseline and after 12 weeks of treatment
quality of life
celiac disease quality of life questionnaire (F-CDQ)
Time frame: baseline and after 12 weeks of treatment
circulating inflammation markers
concentration of cytokines interleukin-6, tumor necrosis factor-alpha and interleukin-10
Time frame: baseline and after 12 weeks of treatment
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