Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2022-09-22
2025-01-01
Brief Summary
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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
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Bovine colostrum
Participant will receive 18g of bovine colostrum with apple sauce and 1g of gluten.
Bovine colostrum
Subject will receive bovine colostrum with gluten.
Placebo
Participant will receive 18g of placebo with apple sauce and 1g of gluten.
Placebo
Subject will receive a placebo with gluten.
Interventions
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Bovine colostrum
Subject will receive bovine colostrum with gluten.
Placebo
Subject will receive a placebo with gluten.
Eligibility Criteria
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Inclusion Criteria
* Willing to provide informed consent for all study procedures
* Healthy volunteer according to the investigator assessment (history and physical exam)
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Milky Way Life Sciences LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jocelyn Silvester, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2019P001133 - clinical
Identifier Type: -
Identifier Source: org_study_id