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Study of the effect of zinc sulfate plus probiotics in outpatient children over 2 years with acute gastroenteritis admitted to the Qom City pediatric clinic during 2011 to 2013
Last registered on May 16, 2014

Pre-Trial

Trial Information
General Information
Title
Study of the effect of zinc sulfate plus probiotics in outpatient children over 2 years with acute gastroenteritis admitted to the Qom City pediatric clinic during 2011 to 2013
RCT ID
AEARCTR-0000381
Initial registration date
May 16, 2014
Last updated
May 16, 2014 2:04 PM EDT
Location(s)
Primary Investigator
Affiliation
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2011-01-01
End date
2013-12-31
Secondary IDs
Abstract
Introduction: Acute gastroenteritis is one of the important causes of mortality in infants and children and one of the six factors of death among children.
Aim: The aim of this study was to compare the effect of Zinc Sulfate and Saccharomyces boulardii probiotic (Yomogi) on children over 2 years with acute gastroenteritis admitted to the pediatric clinic during 2011 to 2013.
Methods: In this clinical trial children were studied in two groups of case and control. The control group received standard treatment of diarrhea (fluid therapy, continuing feeding and Zinc Sulfate syrup 5 cc QID) and case group received Saccharomyces boulardii probiotic capsule with trade name of Yomogi (250 mg daily) in addition to standard treatment. Demographic information, diarrhea status, appetite recovery and mean frequency of diarrhea before and during treatment period were recorded and then data were analyzed.
Results: There were 100 children in each group. Average age of children was 35.93±6.18 months in control group and 37.65±3.64 months in case group. Mean duration of symptoms and times of diarrhea after treatment in the two groups had a significant difference. Also the number of days until recovery, patient’s appetite and satisfaction between two groups had a significant difference. But Age and Gender and the number of times of diarrhea before starting treatment did not have any significant difference and before treatment both groups were similar in terms of severity of disease.
Conclusion: According to this study, a combination of zinc sulfate and saccharomycesboulardii probiotic (yomogi) is recommended in children with acute gastroenteritis.
External Link(s)
Registration Citation
Citation
Jangholi, Ehsan. 2014. "Study of the effect of zinc sulfate plus probiotics in outpatient children over 2 years with acute gastroenteritis admitted to the Qom City pediatric clinic during 2011 to 2013." AEA RCT Registry. May 16. https://doi.org/10.1257/rct.381-1.0
Former Citation
Jangholi, Ehsan. 2014. "Study of the effect of zinc sulfate plus probiotics in outpatient children over 2 years with acute gastroenteritis admitted to the Qom City pediatric clinic during 2011 to 2013." AEA RCT Registry. May 16. https://www.socialscienceregistry.org/trials/381/history/1769
Experimental Details
Interventions
Intervention(s)
Children were divided into two groups of case and control. Control group received standard treatment of diarrhea (fluid therapy and continuing feeding proper for the age and Zinc Sulfate syrup 5cc QID) and case group received Saccharomyces boulardii probiotic capsule with trade name of Yomogi (250 mg daily) in addition to standard treatment. The used syrup was Zinc Sulfate containing Zinc Sulfate Heptahydrate 22mg which each 5ml of it is equivalent to 5mg of Zinc and the used capsule, Yomogi probiotic capsule. Contained 250 mg dried yeast of Saccharomyces boulardii. Patients had to take the capsule with water. Neither of the two groups was given anti-diarrheal drugs or antibiotics
Intervention Start Date
2011-02-01
Intervention End Date
2013-12-31
Primary Outcomes
Primary Outcomes (end points)
Data about underlying variables, diarrhea recovery status, appetite recovery and the mean frequency of diarrhea were asked from mothers over the phone and recorded in the questionnaire before starting treatment and during treatment and then it was considered as recovery if defecation status of the child had got back to normal (before the disease) in terms of number of defecation and the stool form.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Children were divided into two groups of case and control. Control group received standard treatment of diarrhea (fluid therapy and continuing feeding proper for the age and Zinc Sulfate syrup 5cc QID) and case group received Saccharomyces boulardii probiotic capsule with trade name of Yomogi (250 mg daily) in addition to standard treatment. The used syrup was Zinc Sulfate containing Zinc Sulfate Heptahydrate 22mg which each 5ml of it is equivalent to 5mg of Zinc and the used capsule, Yomogi probiotic capsule. Contained 250 mg dried yeast of Saccharomyces boulardii. Patients had to take the capsule with water. Neither of the two groups was given anti-diarrheal drugs or antibiotics. Data about underlying variables, diarrhea recovery status, appetite recovery and the mean frequency of diarrhea were asked from mothers over the phone and recorded in the questionnaire before starting treatment and during treatment and then it was considered as recovery if defecation status of the child had got back to normal (before the disease) in terms of number of defecation and the stool form.
Experimental Design Details
Randomization Method
Public lottery
Randomization Unit
blocks
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
200
Sample size: planned number of observations
200
Sample size (or number of clusters) by treatment arms
100
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
ethic committee of medical science university of Qom
IRB Approval Date
2011-12-01
IRB Approval Number
1137646101
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
December 31, 2013, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
December 31, 2013, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
200
Was attrition correlated with treatment status?
Final Sample Size: Total Number of Observations
200
Final Sample Size (or Number of Clusters) by Treatment Arms
100
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers