Bovine Colostrum to Prevent Absorption of Gluten

NCT05555446 | Suspended Early Phase 1

• 1 other identifier: 2019P001133 - clinical
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Gluten Sensitivity; Non-celiac Gluten Sensitivity

Keywords

celiac disease; gluten; colostrum

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (1)

• Symptom score

  24 hours

Study Arms (2)

Bovine colostrum

EXPERIMENTAL

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

Dietary Supplement: Bovine colostrum

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Bovine colostrum DIETARY_SUPPLEMENT

Subject will receive bovine colostrum with gluten.

Bovine colostrum

Placebo DIETARY_SUPPLEMENT

Subject will receive a placebo with gluten.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milky Way Life Sciences LLC: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jocelyn Silvester, MD PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant and investigator will not be aware whether subject is having the colostrum or the placebo
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will subsequently have either the bovine colostrum and then the placebo or vice-versa

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 26, 2022
• Study Start: September 22, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)