This study is a clinical trial on 100 patients admitted in Pediatrics or Infectious Diseases Wards of Shahid Beheshti Hospital with complaints of fever and bloody diarrhea in 2014. Dysentery is confirmed by stool exam. Patients with severe malnutrition, immune deficiency or using of anti-diarrheal drugs are excluded from the study. Patients randomly assign into two groups. Experimental group receive probiotic as Kidilact prepared by Zist Khavar Company and the control group will receive placebo prepared by Farabi Co. They receive these products every 12 hours for 5 days. Treatment protocols for dysentery shall be conducted in two groups. Duration of fever and bloody diarrhea and hospitalization will be recorded by the question of patients and study of dossier.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060617985N1
Registration date:2014-10-26, 1393/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-26, 1393/08/04
Registrant information
Name
Alireza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic compared with placebo on the duration of dysentery in hospitalized patients
Public title
The effect of probiotc on improvement of dysentery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients hospitalized with fever and bloody diarrhea in pediatrics or infectious diseases wards; Active stool exam
Exclusion criteria: Severe malnutrition; Immune deficiency; Using of anti-diarrheal drugs
Age
From 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
134
Health conditions studied
1
Description of health condition studied
Dysentery
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Fever improvement
Timepoint
Every 6 hours
Method of measurement
Mercury thermometer
2
Description
Stop bloody diarrhea
Timepoint
Daily
Method of measurement
Stool chart
3
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Stool chart
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
At discharge
Method of measurement
Study of records
Intervention groups
1
Description
Intervention group: Oral administration of probiotic (Kidilact) every 12 hours for 5 days
Category
Treatment - Drugs
2
Description
Control group: Oral administration of placebo (like probiotic) every 12 hours for 5 days