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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2016111530906N1 |
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Date of registration:
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2017-02-21 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Studying the effect of probiotics in the prevention of urinary tract infection among elderlies
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Scientific title:
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The effect of probiotics in the prevention of urinary tract infections in elderly patients hospitalized in intensive care units |
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Date of first enrolment:
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2015-10-01 |
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Target sample size:
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53 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/24423 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Maryam Niksolat
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Address:
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Rasool Akram Hospital, Mansouri st., Sattar Khan st.,Tehran
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 218052234 |
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Email:
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dmniksolat@gmail.com |
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Affiliation:
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Iran University of Medical Sciences |
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Name:
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Mahshid Talebitaher
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Address:
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Rasool Akram Hospital, Mansouri st., Sattar Khan st., Tehran
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 218052234 |
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Email:
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mtalebitaher2000@yahoo.com |
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Affiliation:
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Iran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: The inclusion criteria included elder patients who aged sixty and more, and were admitted to the ICU, and did not have any limitation for taking medicine orally; Exclusion criteria: included the patients who had a history of chemotherapy previously and right now, acute bowel obstruction, short bowel syndrome and acute pancreatitis.
Exclusion criteria:
Age minimum:
60 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Urinary tract infection, site not specified Use additional code (B95-B98), if desired, to identify infectious agent.
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Prevention of Urinary Tract Infections.
Urinary tract infection, site not specified Use additional code (B95-B98), if desired, to identify infectious agent.
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Intervention(s)
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Intervention group: Patients in this group received probiotic capsules containing 107 × 5 CFU viable lyophilized bacteria including 4 strains of Lactobacillus (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus Gasser and Lactobacillus Plantarm), twice a day for seven days.
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Placebo
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Intervention 1: Intervention group: Patients in this group received probiotic capsules containing 107 × 5 CFU viable lyophilized bacteria including 4 strains of Lactobacillus (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus Gasser and Lactobacillus Plantarm), twice a day for seven days. Intervention 2: Control group: Patients in this group took the same shape capsules without active ingredient (placebo), twice a day for seven days.
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Control group: Patients in this group took the same shape capsules without active ingredient (placebo), twice a day for seven days
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Prevention
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Primary Outcome(s)
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Leukocyturia. Timepoint: Before intervention and a week after completion of taking the capsules. Method of measurement: Urinary analysis.
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Urinary tract infection. Timepoint: Before intervention and a week after completion of taking the capsules. Method of measurement: urinary culture.
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Secondary Outcome(s)
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Mortality. Timepoint: On 30th day of intervention. Method of measurement: Followed up by phone call.
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Source(s) of Monetary Support
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Iran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Iran University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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