Bovine Colostrum to Prevent Absorption of Gluten

Last updated: November 30, 2024
Sponsor: Milky Way Life Sciences LLC
Overall Status: Suspended

Phase

1

Condition

Celiac Disease

Allergies & Asthma

Allergy (Pediatric)

Treatment

Bovine colostrum

Placebo

Clinical Study ID

NCT05555446
2019P001133 - clinical
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self-reported strict adherence to a gluten-free diet for at least 3 months. This maybe a lifestyle choice, in solidarity with a child or other family/household memberwith celiac disease, because of non-celiac gluten sensitivity or because of celiacdisease.

  • Willing to provide informed consent for all study procedures

  • Healthy volunteer according to the investigator assessment (history and physicalexam)

Exclusion

Exclusion Criteria:

  • Definite or probable gluten exposure during the 72 hours preceding each studyintervention visit

  • Known active gastrointestinal disease.

  • Use of an oral digestive enzyme supplement during the 72 hours preceding each studyintervention (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 interstitialnephritis attributed to PPI, history of PPI-induced diarrhea)

  • Pregnant women (according to pregnancy test)

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Bovine colostrum
Phase: 1
Study Start date:
September 22, 2022
Estimated Completion Date:
January 01, 2025

Study 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).

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02115
    United States

    Site Not Available

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