Bovine Colostrum for Gluten Intolerance

Overseen By Weishu Zhu

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Milky Way Life Sciences LLC

Must not be taking: Digestive enzymes, PPIs

Disqualifiers: Gastrointestinal disease, Severe lactose intolerance, others

Compensation: Varies

Number of Visits: 5

Duration: 5 visits

10 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using an oral digestive enzyme supplement, you must stop it 72 hours before each study visit.

What data supports the effectiveness of the treatment Bovine Colostrum for Gluten Intolerance?

Bovine colostrum has been shown to have antibacterial effects and can help modulate the immune system, which may provide gastrointestinal benefits. It has been used to treat diarrhea in people with immune deficiencies and may help with gut health, suggesting potential benefits for gluten intolerance. ^{1 2 3 4 5}

Is bovine colostrum safe for human consumption?

Bovine colostrum is generally considered safe for humans, with studies showing no significant adverse effects when used as a supplement. However, some people may experience intolerance due to lactose or sensitivity to milk proteins. ^{3 6 7 8 9}

How does the treatment bovine colostrum differ from other treatments for gluten intolerance?

Bovine colostrum is unique because it contains high levels of immunoglobulins (proteins that help fight infections), growth factors, and antimicrobial peptides, which may help improve gut health and reduce symptoms of gluten intolerance. Unlike standard treatments, it is a natural product that supports the immune system and gut lining, potentially offering a holistic approach to managing gluten intolerance. ^{5 6 10 11 12}

What is the purpose of this trial?

This trial investigates whether hyperimmune bovine colostrum can help people on a strict gluten-free diet by reducing the amount of gluten their bodies absorb. The colostrum works like a sponge, soaking up gluten to prevent it from causing problems.

Research Team

Jocelyn Silvester, MD PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for healthy volunteers who have been strictly gluten-free for at least 3 months, whether due to celiac disease, non-celiac gluten sensitivity, or personal choice. Participants must not have active gastrointestinal diseases, severe reactions to gluten or milk proteins, recent use of digestive enzymes, certain medical conditions or medications as judged by the investigators, and cannot be pregnant.

Inclusion Criteria

Willing to provide informed consent for all study procedures

Healthy volunteer according to the investigator assessment (history and physical exam)

You have been strictly following a gluten-free diet for at least 3 months, whether it's because of personal choice, to support a family member with celiac disease, non-celiac gluten sensitivity, or because you have celiac disease yourself.

Exclusion Criteria

Known active gastrointestinal disease.

Use of an oral digestive enzyme supplement during the 72 hours preceding each study intervention (challenge) visit.

Any medication or medical condition which, in the opinion of the investigators, could adversely affect the patient's participation in the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-treatment

Participants receive daily proton pump inhibitor (PPI) therapy (omeprazole 20 mg) at least one week before the first intervention

1 week

Treatment

Participants undergo a double-blind, cross-over study with gluten challenges with either bovine colostrum or placebo

5 visits

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event recording and patient-reported outcomes

3 days

Treatment Details

Interventions

• Bovine colostrum
• Placebo

Trial Overview The study tests if bovine colostrum can prevent the absorption of gluten in people on a strict gluten-free diet. It's a double-blind cross-over trial where participants will unknowingly receive either bovine colostrum or a placebo while being challenged with oral gluten.

Participant Groups

Group I: Bovine colostrum Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Milky Way Life Sciences LLC

Lead Sponsor

Trials

1

Recruited

10+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Immunomodulatory proteins in colostrum]. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical applications of bovine colostrum therapy: a systematic review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Benefits of Bovine Colostrum in Pediatric Nutrition and Health. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Composition and clinical use of bovine colostrums]. [2012]

5. India pubmed.ncbi.nlm.nih.gov

Effect of bovine colostrum-based food supplement in the treatment of HIV-associated diarrhea in Northern Uganda: a randomized controlled trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Bovine Colostrum: Its Constituents and Uses. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Stepwise, Pilot Study of Bovine Colostrum to Supplement the First Enteral Feeding in Preterm Infants (Precolos): Study Protocol and Initial Results. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Nutritional and health effects of bovine colostrum in neonates. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Role of colostrum in gastrointestinal infections. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of wheat gluten in milk replacers and calf starters. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Influence of Bovine Colostrum Supplementation on Leaky Gut Syndrome in Athletes: Diagnostic Biomarkers and Future Directions. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Bovine colostrums: a review of clinical uses. [2019]