NCT03775499

Probiotic BL NCC 2705 and Gluten Sensitivity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Celiac Disease
• Non-celiac Gluten Sensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intervention 1 : BL NCC 2705 + Maltodextrin	2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day
OTHER	Intervention 1 : Maltodextrin	2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day
DIETARY_SUPPLEMENT	Intervention 2 : BL NCC 2705 + Maltodextrin	2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day
OTHER	Intervention 2 : Maltodextrin	2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day

Timeline

• Start date: 2018-10-09
• Primary completion: 2019-10-04
• Completion: 2020-12-15
• First posted: 2018-12-14
• Last updated: 2020-12-23

Locations

1 site across 1 country: Netherlands