Bovine Colostrum to Prevent Absorption of Gluten (NCT05555446) | Clinical Trial Compass
SuspendedEarly Phase 1
Bovine Colostrum to Prevent Absorption of Gluten
Stopped: Disengagement from sponsor, no funding provided since 2022.
United States10 participantsStarted 2022-09-22
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Definite or probable gluten exposure during the 72 hours preceding each study intervention visit
* Known active gastrointestinal disease.
* Use of an oral digestive enzyme supplement during the 72 hours preceding each study intervention (challenge) visit.
* History of severe symptomatic reactions to gluten or milk proteins
* History of allergy to beef or meat
* History of allergy to apple
* Severe lactose intolerance
* 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)
* Pregnant women (according to pregnancy test)