What side effects are associated with this type of intervention?

The primary treatment for Celiac Disease is a strict gluten-free diet, which generally has no direct side effects but can be challenging to maintain and may lead to nutritional deficiencies if not well-balanced. Emerging treatments like hyperimmune bovine colostrum, which aim to reduce gluten absorption, are still under investigation. Potential side effects of such treatments are not well-documented yet, but they may include gastrointestinal discomfort or allergic reactions, similar to other colostrum-based supplements.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Celiac Disease in the provided context. The primary treatment for Celiac Disease remains a strict gluten-free diet. The context does mention a study investigating the use of hyperimmune bovine colostrum to reduce gluten absorption, but it does not provide details on FDA approvals or related drugs for this approach. Therefore, it appears that while dietary management is the cornerstone of Celiac Disease treatment, research into alternative therapies like hyperimmune bovine colostrum is ongoing.

What other types of research exist?

Promising alternatives to hyperimmune bovine colostrum for celiac disease patients include immunomodulators and corticosteroids, which have shown high success rates in related gastrointestinal conditions.

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Immunotherapy

Bovine Colostrum for Gluten Intolerance

Phase < 1

Recruiting

Led By Jocelyn Silvester, MD PhD

Research Sponsored by Milky Way Life Sciences LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include reactions related to lactose intolerance given that bovine colostrum is derived from cow's milk. Also possible are allergic responses in individuals sensitive to beef or other components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gluten immunogenic peptides in urine

Secondary study objectives

Symptom score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bovine colostrumExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bovine colostrum

2014

Completed Phase 2

~200

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Celiac Disease is a strict gluten-free diet, which prevents the immune response triggered by gluten, allowing the intestines to heal. Hyperimmune bovine colostrum is being studied for its potential to reduce gluten absorption, which could help limit the immune response and intestinal damage by reducing the amount of gluten that reaches the small intestine. These mechanisms are crucial for Celiac Disease patients as they emphasize the importance of dietary management and the potential for new therapies to offer additional protection against gluten exposure.