In-vivo Study of the Efficacy of Hyperimmune Bovine Colostrum to Block Absorption of Gliadin Peptides in the Human Intestine: A Novel Potential Intervention for Celiac Disease and Non-celiac Gluten Sensitivity

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Milky Way Life Sciences LLC
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Updated on 27 September 2022
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Accepts healthy volunteers

Summary

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.

Description

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).

Details
Condition Celiac Disease, Gluten Sensitivity, Non-celiac Gluten Sensitivity
Age 18years - 75years
Treatment Placebo, Bovine colostrum
Clinical Study IdentifierNCT05555446
SponsorMilky Way Life Sciences LLC
Last Modified on27 September 2022

Eligibility

 Yes No Not Sure

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)
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How to participate?

Step 1 Connect with a study center

Since this trial requires contact information verification, you will receive an email with the information you provided asking for your validation. Only after this verification step your referral will be sent to the study site selected.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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