The study on the efficacy of available synbiotics in Iran(KidiLacts and PediLacts) on the decrease in duration of acute diarrhea in 6 month to 5 years old outpatients in comparison with standard treatment
The purpose of this double-blind randomized clinical trial(control with standard tretment, phase 3) is studying on the efficacy of synbiotics (probiotic plus prebiotic including KidiLacts and PediLacts) available in Iran on decrease in duration of acute diarrhea in 6 -month to 5 -years -old outpatients.
100 children suffering from acute diarrhea with non-bloody diarrhea whose dehydration is mild to moderate is going to be subjected to the study.( A check list of demographic information and clinical presentation will be given to parents). They are going to be divided into two 50 persons groups (6-month to 2-year-old and 2-year to 5-year-old). PediLact plus ORS randomly will be prescribed to 25 persons of 6 month to 2 year old’s group , 10 drops daily till 5 day and KidiLact plus ORS randomly will be prescribed to 25 persons of 2 year to 5 year old's group, 1 suchet daily till 5 day. 50 persons of controlled group will just receive oral rehydration with ORS as the recommendation of WHO protocols( the intervention groups receive ORS as the same too). Five days later, all the patients are going to be called asking for their physical conditions; if diarrhea is recuperated, if so, its time duration of suffering will be submitted otherwise they will be daily followed up till absolute recovery. Then the comparison between two groups will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071935178N1
Registration date:2017-09-23, 1396/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-23, 1396/07/01
Registrant information
Name
Mitra Aldaghi
Name of organization / entity
Sabzevar University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 514411071
Email address
aldaghim@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Science
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study on the efficacy of available synbiotics in Iran(KidiLacts and PediLacts) on the decrease in duration of acute diarrhea in 6 month to 5 years old outpatients in comparison with standard treatment
Public title
Efficacy of Synbiotics (KididLact and PediLact) in the treatment of acute diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Signed informed consent form by patient's parents ; Patients between 6 months to 5 years old; Patients with acute diarrhea(less than 14 days).
Exclusion criteria: Unwillingness of keeping the research up in any point with any excuse; Patient had severe diarrhea or need venous rehydratin; Patient had chronic diarrhea(more than 14 days); Consuming precedent of antibiotic in this diarrhea cycle; Presence of bloody diarrhea; Age less than 6 months or more than 5 years; Kid suffering from FTT(Failure To Thrive);The patient involved with other organs’ infections (Otitis, Pneumonia, Urinary Tract Infection and etc); The patient has utilized probiotics during a week ago; History of any kind of cancer in the past; Immunocompromised
Age
From 6 months old to 5 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Science
Street address
Sabzevar University of Medical Science, Tohid town, Sabzevar
City
Sabzevar
Postal code
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.MEDSAB.REC.1395.143
Health conditions studied
1
Description of health condition studied
Diarrhea
ICD-10 code
A08
ICD-10 code description
Other gastroenteritis and colitis of infectious and unspecified origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
5 days after intervention and if diarrhea continues; daily
Method of measurement
Day
Secondary outcomes
1
Description
Advers effect of drug
Timepoint
End of intervention
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: First group recieve 1 suchet of Kidilact (for 2 to 5 years old) which is contains 1 gram of 10*9 microorganism, daily for 5 days. For each patient 5 suchet has been considered.
Category
Treatment - Drugs
2
Description
Intervention group: Second group receive synbiotic of Pedilact ( for 6 months to 2 years old) as 10 drops per day until 5 days. Pedilact is a oral drops which contain 15 cc in a bottle with 10*9 microorganism. For each patient one bottle has been considered.
Category
Treatment - Drugs
3
Description
Control group: Standard oral rehydration therapy with powder of ORS( in 1 liter cold boiled water). 10 cc per kilogram after each time of defecation until end of recuperation time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Special and Subspecial Heshmatie Hospital
Full name of responsible person
Zohre Nazemi
Street address
Clinic of Special and Subspecial Heshmatie Hospital, Asad abadi street, Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical Science
Full name of responsible person
Hamidreza Baghani Aval
Street address
Vice chancellor for research, Sabzevar University of Medical Science, Tohid town, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Sabzevar University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical University of Medical Science
Full name of responsible person
Zohre Nazemi
Position
Medical Student
Other areas of specialty/work
Street address
Sabzevar University of Medical Science,Tohid town, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 3821 7987
Fax
Email
z.n8592@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Mitra Aldaghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Depatrment of ejucation, Special and subspecial Heshmatie hospital,Asad abadi street, Sabzevar
City
Sabzevar
Postal code
Phone
+98 514411071
Fax
Email
aldaghim@medsab.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Zohre Nazemi
Position
Medical Student
Other areas of specialty/work
Street address
Sabzevar University of Medical Science, Tohid town, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 3821 7087
Fax
Email
z.n8592@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)