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Clinical trial

Phase I, Single-arm, Dose-escalation Trial of Tributyrin to Promote Gut Health Among Children Undergoing Hematopoietic Cell Transplantation

ID
Name
Pro00112603
Description
To determine the safety and tolerability of tributyrin among children undergoing hematopoietic cell transplantation (HCT).
Trial arms
Trial start
2024-08-01
Estimated PCD
2025-11-01
Trial end
2026-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Tributyrin
Tributyrin is a nutritional supplement prepared by esterification of glycerin with butyric acid that promotes delivery of free butyrate to distal portions of the gut.
Arms:
Tributyrin nutritional supplement
Other names:
Nutritional supplement
Size
30
Primary endpoint
Maximum tolerated dose (MTD) of tributyrin among children undergoing hematopoietic cell transplantation (HCT)
36 months
Eligibility criteria
Inclusion Criteria: * Age 2-17 years with standard of care nasogastric tube placement or existing gastric tubes * Planned allogeneic hematopoietic cell transplantation with myeloablative preparative regimen * Planned graft-versus-host-disease prophylaxis with calcineurin inhibitor + mycophenoalte mofetil or calcineurin inhibitor + methotrexate Exclusion Criteria: * Previous history of hematopoietic cell transplantataion
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-03-01

1 organization

1 product

1 indication

Organization
Duke University
Product
Tributyrin
Indication
Hematopoietic Cell Transplantation