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Bovine Colostrum to Prevent Absorption of Gluten

Primary Purpose

Celiac Disease, Gluten Sensitivity, Non-celiac Gluten Sensitivity

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bovine colostrum
Placebo
Sponsored by
Milky Way Life Sciences LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring celiac disease, gluten, colostrum

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bovine colostrum

Placebo

Arm Description

Participant will receive 18g of bovine colostrum with apple sauce and 1g of gluten.

Participant will receive 18g of placebo with apple sauce and 1g of gluten.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2022
Last Updated
May 22, 2023
Sponsor
Milky Way Life Sciences LLC
Collaborators
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05555446
Brief Title
Bovine Colostrum to Prevent Absorption of Gluten
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milky Way Life Sciences LLC
Collaborators
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Gluten Sensitivity, Non-celiac Gluten Sensitivity
Keywords
celiac disease, gluten, colostrum

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Subjects will subsequently have either the bovine colostrum and then the placebo or vice-versa
Masking
ParticipantInvestigator
Masking Description
Both participant and investigator will not be aware whether subject is having the colostrum or the placebo
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bovine colostrum
Arm Type
Experimental
Arm Description
Participant will receive 18g of bovine colostrum with apple sauce and 1g of gluten.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participant will receive 18g of placebo with apple sauce and 1g of gluten.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bovine colostrum
Intervention Description
Subject will receive bovine colostrum with gluten.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subject will receive a placebo with gluten.
Primary Outcome Measure Information:
Title
Gluten immunogenic peptides in urine
Description
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 Outcome Measure Information:
Title
Symptom score
Description
Intra-subject maximal CDSD scores within a single domain for the 24 hours following gluten challenge (1-10)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weishu Zhu
Phone
617-838-1876
Email
ColostrumResearch@milkywaylifesciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Silvester, MD PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Frank
Phone
617-667-3419
Email
efrank2@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Amelie Therrien, MD MS
First Name & Middle Initial & Last Name & Degree
Jocelyn Silvester, MD PhS

12. IPD Sharing Statement

Plan to Share IPD
No

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Bovine Colostrum to Prevent Absorption of Gluten

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