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

Société Guaranteed Gluten Free (GGF)

Status: Completed

Conditions: Celiac Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Protalsafe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03483805

2016-A00330-51

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Protalsafe product, daily, 12 weeks

Treatment:

Dietary Supplement: Protalsafe

Placebo

Placebo Comparator group

Description:

Placebo product, daily, 12 weeks

Treatment:

Dietary Supplement: Placebo