Your session is about to expire
← Back to Search
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
Awards & highlights
Study Summary
This trial will test whether bovine colostrum can help people with celiac disease by reducing the amount of gluten they absorb.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gluten immunogenic peptides in urine
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
Milky Way Life Sciences LLCLead Sponsor
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,326 Total Patients Enrolled
5 Trials studying Celiac Disease
100 Patients Enrolled for Celiac Disease
Jocelyn Silvester, MD PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to beef or other types of meat in the past.You have eaten foods containing gluten in the 3 days before the study visit.You have had an allergic reaction to apples in the past.You have a serious problem with digesting lactose.You are allergic to PPI or have had bad reactions to using PPI in the past.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.You have had strong reactions to gluten or milk proteins in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Bovine colostrum
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Celiac Disease Patient Testimony for trial: Trial Name: NCT05555446 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I be considered a candidate for this experiment?
"This clinical trial requires 10 individuals with a history of consuming gluten, ranging in age from 18 to 75. Eligibility requirements include having abided by a strict gluten-free diet for at least 3 months due to non-celiac sensitivity or celiac disease, being willing and able to provide informed consent for all study procedures, and passing the investigator's assessment (history & physical examination)."
Answered by AI
How many people are currently enrolled in this research trial?
"Affirmative, the clinicaltrials.gov directory confirms that recruitment is currently ongoing for this research project which was first posted on September 22nd 2022 and last amended on the same date. The study needs to enroll 10 individuals from a single site."
Answered by AI
Are the parameters of this research experiment open to those under 30 years old?
"In keeping with the trial's enrollment requirements, participants must be aged 18 or above and no older than 75."
Answered by AI
Is access to this experiment still available for participants?
"Yes, the data hosted on clinicaltrials.gov confirms that this study is actively seeking candidates. The trial went live on September 22nd 2022 and has since been updated to include a desire for 10 participants to be enrolled from one location."
Answered by AI
Who else is applying?
What state do they live in?
New York
Massachusetts
Florida
Other
What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How long do the screening visits take and what do they consist of? If found to be eligible, what can I expect for treatment and time donated? Is there any compensation for taking part in this study?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I work in clinical research at BMC and understand how important this work is. I want to do my part in helping those with celiac disease!
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger