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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bovine colostrum, a type of milk from cows, can reduce gluten absorption in individuals sensitive or allergic to gluten. Participants will receive either the colostrum or a placebo (a non-active substance) along with a small amount of gluten to determine if the colostrum makes a difference. It suits those who have strictly followed a gluten-free diet for at least three months, whether due to celiac disease or personal choice. The study aims to determine if this natural product could more effectively manage gluten intolerance. As an Early Phase 1 trial, this research focuses on understanding how bovine colostrum works in people, offering participants a chance to be among the first to explore its potential benefits.

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.

Is there any evidence suggesting that bovine colostrum is likely to be safe for humans?

Research has shown that bovine colostrum is usually safe for people. Studies indicate that using it as a supplement does not lead to major side effects. However, some individuals might experience mild reactions, especially if sensitive to cow's milk. Those with concerns should consult a healthcare professional before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Bovine colostrum is unique because it is a natural substance derived from cow's milk, packed with antibodies and growth factors that may help protect the gut lining. This is different from most current treatments for gluten intolerance, which often focus on managing symptoms rather than preventing them. Researchers are excited because bovine colostrum could potentially offer a new way to reduce gluten sensitivity by strengthening the gut barrier, offering hope for people who struggle with this condition.

What evidence suggests that bovine colostrum might be an effective treatment for gluten intolerance?

This trial will compare the effects of bovine colostrum with a placebo for individuals with gluten intolerance. Research suggests that bovine colostrum might help by reducing the amount of gluten absorbed by the body. Studies have shown that bovine colostrum can make the gut less "leaky," potentially leading to reduced gluten absorption. This could benefit those who need to follow a strict gluten-free diet. Although direct evidence on colostrum specifically reducing gluten absorption is limited, its potential to support gut health is encouraging. More research is needed to confirm its effectiveness for gluten intolerance, but early results are promising. ^{1 2 4 6 7}

Who Is on the Research Team?

Jocelyn Silvester, MD PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05555446

Bovine Colostrum to Prevent Absorption of Gluten Study Overview. To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption. A double-blind, cross-over study will be performed in which ...

2. withpower.com withpower.com/trial/early-phase-1-celiac-disease-8-2022-425c5

Bovine Colostrum for Gluten Intolerance · Info for Participants 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.

3. ctv.veeva.com ctv.veeva.com/study/bovine-colostrum-to-prevent-absorption-of-gluten

Bovine Colostrum to Prevent Absorption of Gluten To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption. A double-blind, cross-over study will be performed in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1044532325000326

Immune therapies in coeliac disease and food allergies IMGX003 (Latiglutenase) showed efficacy in a Phase 2b trial to reduce small intestinal mucosal damage and symptom severity in CD patients exposed to 2 g of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5409709/

Oral Supplementation with Bovine Colostrum Decreases ... Colostrum bovinum supplementation was safe and effective in decreasing of intestinal permeability in this series of athletes at increased risk of its elevation.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900709000458

Bovine milk intolerance in celiac disease is related to IgA ... Different approaches have been done to detect the component responsible for this problem, including the possibility of gluten peptides present in cow's milk.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7881392/

The potentials of probiotics on gluten hydrolysis; a review study Research has shown that treatment with probiotics in CD patients could improve the symptoms by the gluten hydrolysis.