Bovine Colostrum to Prevent Absorption of Gluten

Early Phase 1SuspendedNCT05555446

Milky Way Life Sciences LLC10 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Celiac Disease Gluten Sensitivity Non-celiac Gluten Sensitivity

Interventions

Bovine colostrumDIETARY_SUPPLEMENT

Subject will receive bovine colostrum with gluten.

PlaceboDIETARY_SUPPLEMENT

Subject will receive a placebo with gluten.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Gluten immunogenic peptides in urine

The main outcome measure will be the intra-subject area under the curve (AUC) for gluten immunogenic peptides measured in urine following gluten challenge with placebo compared to the AUC for gluten immunogenic peptides following gluten challenge combined with colostrum

Time frame: 24 hours

Secondary Outcomes

Symptom score

Intra-subject maximal CDSD scores within a single domain for the 24 hours following gluten challenge (1-10)

Time frame: 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.