Език: EN EN
← Назад към резултатите
Набира участници Фаза 2 NCT05579639

Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Allogeneic Stem Cell Transplantation

Спонсор: Children's Hospital Medical Center, Cincinnati

Налично на: БГ
Обобщение
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.
Описание
Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo allogeneic stem cell transplant (SCT).
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record * Cranial boost in patients receiving total body irradiation * Known history of allergy to xylitol * Known history of allergy to grapes or grape flavoring * Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)
Интервенции
Xylitol
OTHER
Placebo
OTHER
Места на провеждане 3
САЩ (3)
Children's Hospital Colorado
Aurora , Colorado
Dana-Farber/Boston Children's
Boston , Massachusetts
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
4 Months
Максимална възраст
25 Years
Здрави доброволци
Не
Начална дата
04.04.2023
Крайна дата
30.06.2027
Регистрационен номер
NCT05579639
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.