Bovine Colostrum to Prevent Absorption of Gluten
NCT05555446 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-12-04
Summary
To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption.
A double-blind, cross-over study will be performed in which persons who are following a strict gluten-free diet will be challenged with oral gluten with or without the bovine colostrum.
Conditions
- Celiac Disease
- Gluten Sensitivity
- Non-celiac Gluten Sensitivity
Interventions
- DIETARY_SUPPLEMENT
-
Bovine colostrum
Subject will receive bovine colostrum with gluten.
- DIETARY_SUPPLEMENT
-
Placebo
Subject will receive a placebo with gluten.
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Milky Way Life Sciences LLC
lead INDUSTRY
Principal Investigators
-
Jocelyn Silvester, MD PhD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-22
- Primary Completion
- 2025-01-01
- Completion
- 2025-01-01
Countries
- United States
Study Locations
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