Bovine Colostrum to Prevent Absorption of Gluten
Reason given: Disengagement from sponsor, no funding provided since 2022.
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Early phase 1
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
Trial details
- Who runs it
- Milky Way Life Sciences LLC
- Trial code
- NCT05555446
- Record updated
- 4 December 2024
- Original description
To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption.Read full original descriptionShow less
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
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.
Inclusion: Self-reported strict adherence to a gluten-free diet for at least 3 months. This may be a lifestyle choice, in solidarity with a child or other family/household member with celiac disease, because of non-celiac gluten sensitivity or because of celiac disease; Willing to provide informed consent for all study procedures; Healthy volunteer according to the investigator assessment (history and physical exam).
Exclusion: Known active gastrointestinal disease; History of severe symptomatic reactions to gluten or milk proteins; History of allergy to beef or meat; History of allergy to apple; Any medication or medical condition which, in the opinion of the investigators, could adversely affect the patient's participation in the trial; Allergy to PPI or other contraindication for PPI use (i.e history of interstitial nephritis attributed to PPI, history of PPI-induced diarrhea); Definite or probable gluten exposure during the 72 hours preceding each study intervention visit; Use of an oral digestive enzyme supplement during the 72 hours preceding each study intervention (challenge) visit; Severe lactose intolerance; Pregnant women (according to pregnancy test).