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NCT05555446
Bovine Colostrum to Prevent Absorption of Gluten
EARLY_PHASE1 trial testing Bovine colostrum in Celiac Disease in 10 participants. Suspended.
1 January 2025
Quick facts
| Lead sponsor | Milky Way Life Sciences LLC |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 22 September 2022 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bovine colostrum
- Placebo
Conditions studied
- Celiac Disease — all drugs for Celiac Disease →
- Gluten Sensitivity — all drugs for Gluten Sensitivity →
- Non-celiac Gluten Sensitivity — all drugs for Non-celiac Gluten Sensitivity →
Sponsor
Milky Way Life Sciences LLC
Who can join
Adults 18 to 75, any sex, with Celiac Disease or Gluten Sensitivity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evolution in coeliac disease diagnosis and management.
Tye-Din JA. · · 2024 · cited 8× · PMID 38957478 · DOI 10.1002/jgh3.13107
Verify or expand the search:
- PubMed search for NCT05555446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bovine colostrum
Trials testing the same drug.
- NCT06164600 — Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children · Phase 2 · completed
- NCT03926390 — Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial · NA · completed
Other recruiting trials for Celiac Disease
Currently open trials in the same condition.
- NCT07239336 — Study of DONQ52 in Active Celiac Disease · Phase 2 · recruiting
- NCT07585669 — Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease · NA · recruiting
- NCT07063823 — A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease · Phase 1 · recruiting
- NCT06982963 — Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease · Phase 2 · recruiting
- NCT07177287 — The Effect of a Navigator Nurse- Supported Mobile Application Developed Based on the IMB Model on the Quality of Life of · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05555446 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Milky Way Life Sciences LLC
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05555446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing