A Phase 2 interventional study of Xylitol and Placebo in Allogeneic Hematopoietic Cell Transplantation, sponsored by Children's Hospital Medical Center, Cincinnati. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 2, Interventional, and Prevention
The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.
Our long-term goal is to develop and disseminate clinically relevant, and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral injured mucosa .
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 134 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.
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Exclusion Criteria:
Drug: Xylitol
Other: Placebo
Xylitol dental wipes
Placebo dental wipes
Incidence of bacteremia in the first 30 days post-HSCT with oral organisms
Time frame: 30 days
Incidence of bacteremia in the first 30 days post-HSCT with any organism
Time frame: 30 days
Incidence of dental plaque
Time frame: 30 days
Incidence of gingival inflammation
Time frame: 30 days
Incidence of mucosal ulceration
Time frame: 30 days
Incidence of oral mucositis
Time frame: 30 days
Incidence of oral microbiome diversity
Time frame: 30 days
Incidence of oral pathogenic bacteria burden
Time frame: 30 days
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Xylitol
Children's Hospital Medical Center, Cincinnati →