Bone Marrow Transplant Clinical Trials

Clinical trials related to Bone Marrow Transplant Procedure

Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant: a Randomized, Multicenter, Double-blind , Placebo-controlled Study Evaluating Twice Daily Oral Xylitol

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 25
Healthy Volunteers: f
View:

• Provide signed and dated informed consent and assent (when applicable) form

• Willing to comply with all study procedures and be available for the duration of the study

• Admitted and planning to undergo an allogeneic stem cell transplant (SCT) at Cincinnati Children's Hospital Medical Center (CCHMC), Boston Children's Hospital, or Children's Hospital of Colorado (Denver).

• Male or female, 4 months to 25 years of age at the time of SCT (Day 0)

• Have a minimum of one tooth

• Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Massachusetts
Dana-Farber/Boston Children's
RECRUITING
Boston
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Kelly McIntosh
Kelly.McIntosh@cchmc.org
513-803-0460
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 419
Treatments
Experimental: Xylitol
Xylitol, a naturally occurring sugar alcohol found in plums, strawberries, and various vegetables such as cauliflower, has been approved for use in food by the US FDA since 1963. Spiffies Xylitol Wipes will be used.
Placebo_comparator: Grape-flavored Wipes
Grape-flavored wipes will be used with 2 drops of PCCA colorless grape flavoring. The grape-flavored wipes each contain a solution of 0.9% Sodium Chloride, purified water, and Benzalkonium chloride. PCCA artificial colorless grape flavoring will be used. The PCCA grape flavoring contains propylene glycol, ethyl alcohol, and artificial flavoring.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

This content was sourced from clinicaltrials.gov