Bovine Colostrum to Prevent Absorption of Gluten

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555446
• Other study ID #: 2019P001133 - clinical
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 22, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: Milky Way Life Sciences LLC
• Contact: Weishu Zhu
• Phone: 617-838-1876
• Email: ColostrumResearch[@]milkywaylifesciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Celiac Disease
• Gluten Sensitivity
• Hypersensitivity
• Non-celiac Gluten Sensitivity

Intervention

Dietary Supplement:
• Bovine colostrum
Subject will receive bovine colostrum with gluten.
• Placebo
Subject will receive a placebo with gluten.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Milky Way Life Sciences LLC	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptom score	Intra-subject maximal CDSD scores within a single domain for the 24 hours following gluten challenge (1-10)	24 hours