Celiac Disease, Gluten Sensitivity, Non-celiac Gluten Sensitivity
Conditions
Keywords
celiac disease, gluten, colostrum
Brief summary
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.
Detailed description
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 proton pump inhibitor (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 24 hours 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 patient reported outcome (PRO) recording period).
Interventions
DIETARY_SUPPLEMENTBovine colostrum
Subject will receive bovine colostrum with gluten.
DIETARY_SUPPLEMENTPlacebo
Subject will receive a placebo with gluten.
Sponsors
Beth Israel Deaconess Medical Center
Milky Way Life Sciences LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both participant and investigator will not be aware whether subject is having the colostrum or the placebo
Intervention model description
Subjects will subsequently have either the bovine colostrum and then the placebo or vice-versa
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gluten immunogenic peptides in urine | 24 hours | The main outcome measure will be the intra-subject area under the curve (AUC) for gluten immunogenic peptides measured in urine following gluten challenge with placebo compared to the AUC for gluten immunogenic peptides following gluten challenge combined with colostrum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom score | 24 hours | Intra-subject maximal CDSD scores within a single domain for the 24 hours following gluten challenge (1-10) |
Countries
United States
Outcome results
None listed