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| Name | Class |
|---|---|
| Institut Polytechnique UniLaSalle | UNKNOWN |
| Institut Pasteur de Lille | OTHER |
| Association Française des Intolérants au Gluten (AFDIAG) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Protalsafe product, daily, 12 weeks |
|
| Placebo | Placebo Comparator | Placebo product, daily, 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protalsafe | Dietary Supplement | mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Pasteur de Lille | Lille | France |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Dietary Supplement | maize maltodextrin in powder form, to be diluted in water |
|
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |