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NCT00476450
Effects of Stem Cell Transplantation on Bacteria in the Mouth
trial in Allogeneic Peripheral Blood Stem Cell Transplant in 50 participants. Completed in 7 March 2016.
Quick facts
| Lead sponsor | National Institutes of Health Clinical Center (CC) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 16 May 2007 |
| Estimated completion | 7 March 2016 |
| Sites | 1 location across United States |
Conditions studied
- Allogeneic Peripheral Blood Stem Cell Transplant — all drugs for Allogeneic Peripheral Blood Stem Cell Transplant →
Sponsor
National Institutes of Health Clinical Center (CC)
Who can join
18 and older, any sex, with Allogeneic Peripheral Blood Stem Cell Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will examine bacteria in patients mouths at different times during stem cell transplantation and recovery. Drugs patients receive as part of the conditioning process for a stem cell transplant increase their risk of infection. There might be a link between the bacteria in the mouth and the bacteria that can cause infections. Knowing the changes in bacteria might help researchers determine the best method to prevent infections. Patients 18 years of age and older who are scheduled to receive a stem cell transplant may be eligible for this study. Participants undergo the following procedures: Review of medical records Interview about their oral care Oral examination Collection of oral specimens just before the stem cell transplant, immediately after the transplant, and 3 weeks after the transplant. The specimens are obtained as follows: * \<TAB\>-About one-fourth teaspoon of saliva is collected with a suction device similar to that used in a dental office. * \<TAB\>-Plaque from the surface of a tooth is collected with a plastic toothpick. * \<TAB\>-Skin cells from the inside of the cheek and the surface of the tongue are collected with a small soft brush. * \<TAB\>-If a tube is inserted into the patient s lungs to assist breathing and the patient is admitted to the intensive care unit, a specimen from the lungs is collected. Patients are followed for 100 days after their transplant. Additional oral specimens are obtained from those who develop signs and symptoms of respiratory infection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00476450 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC)
- Last refreshed: 6 October 2017
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing