11 completed, 2 terminated, 1 active not recruiting, 1 recruiting. 11 Not applicable, 2 Phase 1, 2 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 11 | Completed 9, Recruiting 1, Unknown 1 |
| Phase 1 | 2 | Completed 1, Terminated 1 |
| Phase 2 | 2 | Active not recruiting 1, Terminated 1 |
| Phase 3 | 1 | Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) - Hematologic Malignancy | Phase 2 | Terminated | Prolacta Bioscience | 46 | 2023-09-18 | 2024-08-19 |
| Dietary Supplement With and Without a Probiotic and/or Antibiotic Antibiotic, HMO Concentrate, Probiotic - Healthy Adults | Completed | Prolacta Bioscience | 92 | 2021-09-21 | 2025-02-17 | |
| Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC) Humavant - Prematurity, Vascular Aging | Not applicable | Recruiting | Prolacta Bioscience | 200 | 2020-10-09 | 2026-09-18 |
| Dietary Supplement With and Without a Probiotic Complex oligosaccharide, Probiotic, PPI - Healthy Adult Subjects | Not applicable | Completed | Prolacta Bioscience | 62 | 2020-03-13 | 2025-03-18 |
| Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease Prolacta - Growth Delay | Not applicable | Unknown | University of Texas at Austin | 1 | 2019-11-20 | 2020-01-18 |
| Human Milk Fortification in Extremely Preterm Infants H2MF, Bovine milk-based fortifier - Necrotizing Enterocolitis, Sepsis | Phase 2 / Phase 3 | Active not recruiting | Thomas Abrahamsson, MD, PhD | 229 | 2019-02-01 | 2024-07-23 |
| A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea PBCLN-003, Placebo - Clostridium Difficile Diarrhea | Phase 1 | Terminated | Prolacta Bioscience | 26 | 2018-12-06 | 2020-10-19 |
| Human Milk for Congenital Gastrointestinal Disorders Human Milk - Congenital Gastrointestinal Disorders | Not applicable | Completed | Emory University | 151 | 2018-07-26 | 2023-08-28 |
| Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants H2MF - Very Low Birth Weight Baby, Premature Birth | Not applicable | Completed | University of Manitoba | 30 | 2017-08-01 | 2019-09-30 |
| Safety Study of Human Milk Oligosaccharides in Healthy Adults PBCLN-003 - Healthy | Phase 1 | Completed | Prolacta Bioscience | 32 | 2016-09-29 | 2022-08-25 |
| Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology Human Milk Derived Fortifier, Human/Bovine Milk - Congenital Heart Defect | Not applicable | Completed | The University of Texas Health Science Center at San Antonio | 16 | 2016-07-01 | 2023-09-26 |
| Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants Cream Supplement group - Bronchopulmonary Dysplasia | Not applicable | Completed | Baylor College of Medicine | 210 | 2015-06-10 | 2026-01-29 |
| Donor Human Milk in Young Children Receiving Bone Marrow Transplantation Breastmilk - Bone Marrow Transplant - Autologous or Allogeneic | Not applicable | Completed | Children's Hospital Medical Center, Cincinnati | 42 | 2015-03-01 | 2020-08-20 |
| Human Milk Cream as a Caloric Supplement in Pre-Term Infants Human Milk Cream - Prematurity | Not applicable | Completed | Baylor College of Medicine | 78 | 2011-12-01 | 2026-01-29 |
| Nutritional Content of Breast Milk From Mothers of Premies Prematurity, Nutrition | Withdrawn | Pediatrix | 2009-12-01 | 2017-03-23 | ||
| Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula - Infant, Very Low Birth Weight | Not applicable | Completed | Prolacta Bioscience | 260 | 2007-07-01 | 2010-02-18 |
| Evaluation of Prolact-Plus Human Milk Fortifier Prolact-Plus Human Milk Fortifier - Infant, Very Low Birth Weight | Not applicable | Completed | Prolacta Bioscience | 105 | 2006-08-01 | 2021-09-17 |
Premature Birth (7) · Breast Feeding (2) · Bronchopulmonary Dysplasia (1) · Communicable Diseases (1) · Digestive System Diseases (1) · Disease (1) · Enterocolitis, Necrotizing (1) · Heart Defects, Congenital (1) · Hematologic Neoplasms (1) · Sepsis (1) · Univentricular Heart (1)
Probiotics (2) · Anti-Bacterial Agents (1) · Dietary Supplements (1) · Health Maintenance Organizations (1) · Histamine H2 Antagonists (1) · Milk, Human (1)
United States (14) · Austria (3) · Canada (1) · Sweden (1)
Amy B Hair, MD (2) · Cynthia Blanco, MD (1) · David J Rechtman, MD (1) · Geert T'Jong (1) · Heidi Karpen, MD (1) · Martin L Lee, PhD (1) · Meghan Azad, PhD (1) · Reese Clark, MD (1) · Richard J Schanler, MD (1) · Stella Davies, MB.BS, PhD, MRCP (1) · Thomas R Abrahamsson, MD, PhD (1) · Ursula Kiechl-Kohlendorfer, MD, MSc (1)
PMID 20036378, PMID 22534258, PMID 23968744, PMID 25130571, PMID 27331420, PMID 32964431, PMID 33226632, PMID 34332629, PMID 34815288, PMID 36029771, PMID 36528055, PMID 37652940, PMID 38545091, PMID 39239939, PMID 42481630