Bovine Colostrum to Prevent Absorption of Gluten

Milky Way Life Sciences

Status and phase: Enrolling; Early Phase 1

Conditions: Gluten Sensitivity; Celiac Disease; Non-celiac Gluten Sensitivity

Treatments: Dietary Supplement: Bovine colostrum; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05555446

2019P001133 - clinical

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Bovine colostrum

Experimental group

Description:

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

Treatment:

Dietary Supplement: Bovine colostrum

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo