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

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.

Study Overview

• Status: Suspended
• Conditions: Celiac Disease; Gluten Sensitivity; Non-celiac Gluten Sensitivity
• Intervention / Treatment: Dietary supplement: Bovine colostrum; Dietary supplement: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bovine colostrum; Participant will receive 18g of bovine colostrum with apple sauce and 1g of gluten.	Dietary supplement: Bovine colostrum; Subject will receive bovine colostrum with gluten.
Placebo Comparator: Placebo; Participant will receive 18g of placebo with apple sauce and 1g of gluten.	Dietary supplement: Placebo; Subject will receive a placebo with gluten.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom score	Intra-subject maximal CDSD scores within a single domain for the 24 hours following gluten challenge (1-10)	24 hours

Collaborators and Investigators

• Sponsor: Milky Way Life Sciences LLC
• Collaborators: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Jocelyn Silvester, MD PhD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: colostrum; celiac disease; gluten
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Hypersensitivity; Celiac Disease
• Other Study ID Numbers: 2019P001133 - clinical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No