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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.