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
First published
May 16, 2014, 2:04 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
December 31, 2013, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
December 31, 2013, 12:00 +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, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials