Probiotic BL NCC 2705 and Gluten Sensitivity
NCT03775499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2020-12-23
Summary
The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.
Conditions
- Celiac Disease
- Non-celiac Gluten Sensitivity
Interventions
- 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
Sponsors & Collaborators
-
Société des Produits Nestlé (SPN)
lead INDUSTRY
Principal Investigators
-
Carmine D'Urzo, Dr. · Nestec Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-09
- Primary Completion
- 2019-10-04
- Completion
- 2020-12-15
Countries
- Netherlands
Study Locations
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