Bovine Colostrum to Prevent Absorption of Gluten

Study Purpose

We propose 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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)

    Exclusion Criteria:

    - 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05555446
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Milky Way Life Sciences LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jocelyn Silvester, MD PhD
Principal Investigator Affiliation Beth Israel Deaconess Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease, Gluten Sensitivity, Non-celiac Gluten Sensitivity
Additional Details

We will perform a physiologic double-blind, cross-over, study in which volunteers on a gluten-free diet will ingest gluten with or without colostrum. Subject Participation and Study Duration. The study will imply 5 visits for each participant. At the second and fourth visit, they will either take gluten with colostrum powder or with a placebo. Follow-up duration will be until three days after the last study visit. Each participant will be given daily PPI therapy (omeprazole 20 mg) at least one week before the first intervention, and for the entire duration of the study. Each participant will be invited to fill a celiac disease patient reported outcomes questionnaire (Celiac Disease Symptoms Diary) for the 24 hours prior the study intervention and three days after. Blood and urine samples will be collected during the 24hours following each study intervention (gluten + colostrum or gluten + placebo) Adverse events will be recorded during the entire study from enrollment to termination (termination will occur 3 days after the second challenge at the end of the PRO recording period).

Arms & Interventions

Arms

Experimental: Bovine colostrum

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

Placebo Comparator: Placebo

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

Interventions

Dietary Supplement: - Bovine colostrum

Subject will receive bovine colostrum with gluten.

Dietary Supplement: - Placebo

Subject will receive a placebo with gluten.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

Site Contact

Luyang Liu

lliu18@bidmc.harvard.edu

617-667-3419

The content provided by the Celiac Disease Foundation on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Privacy Policy and Terms of Use.