NCT05555446

Bovine Colostrum to Prevent Absorption of Gluten

In-vivo Study of the Efficacy of Hyperimmune Bovine Colostrum to Block Absorption of Gliadin Peptides in the Human Intestine: a Novel Potential Intervention for Celiac Disease and Non-celiac Gluten Sensitivity

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Milky Way Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Physiologic double-blind, cross-over, study in which volunteers on a gluten-free diet will ingest gluten with or without colostrum. Subject Participation and Study Duration The study will imply 5 visits for each participant. At the second and fourth visit, they will either take gluten with colostrum powder or with a placebo. Follow-up duration will be until three days after the last study visit. Each participant will be given daily proton pump inhibitor (PPI) therapy (omeprazole 20 mg) at least one week before the first intervention, and for the entire duration of the study. Each participant will be invited to fill a celiac disease patient reported outcomes questionnaire (Celiac Disease Symptoms Diary) for the 24 hours prior the study intervention and three days after. Blood and urine samples will be collected during the 24 hours following each study intervention (gluten + colostrum or gluten + placebo) Adverse events will be recorded during the entire study from enrollment to termination (termination will occur 3 days after the second challenge at the end of the patient reported outcome (PRO) recording period).

Conditions

• Celiac Disease
• Gluten Sensitivity
• Non-celiac Gluten Sensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bovine colostrum	Subject will receive bovine colostrum with gluten.
DIETARY_SUPPLEMENT	Placebo	Subject will receive a placebo with gluten.

Timeline

• Start date: 2022-09-22
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2022-09-26
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States