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Probiotic BL NCC 2705 and Gluten Sensitivity

Celiac Disease Clinical Trial

Official title:
Proof of Concept Clinical Trial of Safety and Biological Activity of Bifidobacterium Longum NCC 2705 in Gluten Sensitivity

Clinical Trial Summary

The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.

Clinical Trial Description

This trial is a multicenter, double blind, randomized, placebo controlled, 2 by 2 cross-over design (i.e. 2-sequences, 2-periods, 2-treatments) for each specific population (i.e. self-reported Non Coeliac Gluten Sensitivity and Coeliac Disease subjects). 1 capsule of BL NCC 2705 or placebo will be given twice a day in the morning and in the evening with a meal over 2 periods of 4 days. On day four a single dose of gluten (3g) will be administered and duodenal fluid will be collected in the following hours through a naso-intestinal catheter. The viability of BL NCC 2705, the production of serpin and its effects on gluten digestion and intestinal enzymatic activity will be determined. No chronic administration of gluten as a challenge is foreseen in the study. After a wash out period of minimum 2 weeks, period will be repeated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03775499
Study type Interventional
Source Nestlé
Contact
Status Completed
Phase N/A
Start date October 9, 2018
Completion date December 15, 2020
View Details
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