Clinical trial NCT05555446: 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
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Celiac Disease
Gluten Sensitivity
Non-celiac Gluten Sensitivity
Keywords: celiac disease
gluten
colostrum
Lead sponsor: Milky Way Life Sciences LLC
Sponsor class: INDUSTRY
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2022-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will subsequently have either the bovine colostrum and then the placebo or vice-versa
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Gluten immunogenic peptides in urine
timeFrame: 24 hours
Secondary outcomes:
measure: Symptom score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jocelyn Silvester, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: