Comparison of multiple with once-daily nystatin regimens in prevention of oropharyngeal candidiasis in kidney transplant recipients
Design
This open-label clinical trial with parallel-group and phase 3 study will be conducted on 40 patients. Randomization will be performed using Random Allocation software.
Settings and conduct
In this study, kidney transplant patients hospitalized in Urmia Imam Khomeini Hospital will be included in the study. 40 patients will be divided into two equal groups. In one group, patients will receive 30 cc of nystatin once daily, and in the other group, 10 cc three times a day for one month. The study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
Patients undergoing kidney transplantation and treatment with immunosuppressive drugs will be included in the study. The main exclusion criteria are receiving antifungal medication due to fungal infection other than the mouth and throat, intolerance to nystatin, and non-adherence to the prescribed medication regimen.
Intervention groups
Participants in the first group will receive nystatin oral suspension 30 cc once daily for at least one month or until the prednisolone dose is reduced to 10 mg/day or less. Participants in the second group will receive nystatin oral suspension three times daily, 10 mL each time. All patients will instructed to keep the medication in the mouth for at least one minute before swallowing and to avoid eating or drinking for 30 minutes afterward. Nystatin prophylaxis will be done on the first day after transplantation.
Main outcome variables
Oropharyngeal candidiasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260804070532N1
Registration date:2026-08-10, 1405/05/19
Registration timing:retrospective
Last update:2026-08-10, 1405/05/19
Update count:0
Registration date
2026-08-10, 1405/05/19
Registrant information
Name
Shahram Ghiyasvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 8003
Email address
ghiyasvand@live.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of multiple with once-daily nystatin regimens in prevention of oropharyngeal candidiasis in kidney transplant recipients
Public title
Comparison of multiple with once-daily nystatin regimens in prevention of oropharyngeal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney transplant patients
Patients undwrwent immunosuppressive therapy
Age over 18 years
Exclusion criteria:
Receipt of systemic antifungal therapy for a fungal infection other than oropharyngeal candidiasis
Intolerance to nystatin
Non-adherence to the prescribed medication regimen
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patient's will randomly assigned to two groups using a block randomization method based on computer-generated random numbers produced by the Random Allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital; Urmia University of Medical Sciences
First, second, third and fourth weeks after intervention
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Time of development of oropharyngeal candidiasis
Timepoint
First, second, third and fourth weeks after intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: Participants in the first group will receive nystatin oral suspension 30 cc once daily for one month. The patient will hold the medicine in their mouth for at least a minute, then swallow and will not eat anything for half an hour.
Category
Treatment - Drugs
2
Description
Intervention group: Partients in the first group will receive nystatin oral suspension three times daily, 10 mL each time, for one month. The patient will hold the medicine in their mouth for at least a minute, then swallow and will not eat anything for half an hour.