Evaluating the therapeutic effect of synbiotics on acute diarrhea in admitted children aged between 6-24 months; A randomized double blind placebo controlled trial
Evaluating the therapeutic effect of synbiotics on acute diarrhea in admitted children aged between 6-24 months
Design
Pragmatic, Community based, Parallel groups, double blind, randomized controlled trial.
Settings and conduct
This study will be done in the digestive ward Aboozar hospital of Ahvaz. This study will be double blinded of interventions. Blinding technique will be samed in shape, color, size and taste in the study group.
Participants/Inclusion and exclusion criteria
Inclusion: Children with diarrhea age is 24 to 6 months; Patients with acute non-bacterial diarrhea; The duration of diarrhea is less than two days; Patients with moderate dehydration; Patients with acute non-bloody diarrhea; Exclusion: Patients with severe dehydration; Children who show no weight gain; Children who have taken antibiotics during diarrhea; Children who have severe vomiting; Children who have seizures.
Intervention groups
Intervention group: Synbiotic drop orally at dose of 5 drops/day, one time daily for 5 days
Main outcome variables
Reduced hospitalization time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181231042190N1
Registration date:2019-02-27, 1397/12/08
Registration timing:prospective
Last update:2019-02-27, 1397/12/08
Update count:0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Azadeh Arefian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 2715
Email address
azadeh.aref@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-10, 1397/12/19
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the therapeutic effect of synbiotics on acute diarrhea in admitted children aged between 6-24 months; A randomized double blind placebo controlled trial
Public title
Effect of synbiotics in treatment of diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with diarrhea whose age is 24 to 6 months.
Patients with acute non-bacterial diarrhea.
The duration of diarrhea is less than two days.
Patients with moderate dehydration.
Patients with acute non-bloody diarrhea.
Patients who use breast milk.
Patients who have not taken antibiotics over the past two weeks.
Patients whose parents have signed a consent form.
Exclusion criteria:
Patients with severe dehydration.
Children who show no weight gain.
Children who have taken antibiotics during diarrhea.
Children who have severe vomiting.
Children who have seizures.
Patients found in their stool samples have inflammatory cells.
Patients with a history of a variety of metabolic diseases.
Children with a history of blood disorders and anemia.
Patients with a history of a variety of digestive diseases.
Patients who use formula milk.
Patients with acute bloody diarrhea.
Age
From 6 months old to 24 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the 4-block method, individuals will be divided randomly into two equal groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and nurses who prescribed medications to patients are blinded to the type of drugs. The main drug and placebo are the same in the terms of shape, size, taste and packaging. The physician that collect treatment outcomes will not be blinded allocation of interventions.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences.
Street address
Golestan street, Shahr Daneshgahi, Deputy of Research and Technology Development of Ahvaz Jondishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-09-21, 1397/06/30
Ethics committee reference number
IR.AJUMS.REC.1397.424
Health conditions studied
1
Description of health condition studied
Non infectious acute diarrhea
ICD-10 code
P78.3
ICD-10 code description
Noninfective neonatal diarrhea
Primary outcomes
1
Description
Time of Hospitalization
Timepoint
The duration of treatment
Method of measurement
The duration of hospitalization
Secondary outcomes
1
Description
Pharmaceutical allergy
Timepoint
The duration of treatment
Method of measurement
Clinical observation
Intervention groups
1
Description
Intervention group: Synbiotic drop orally at dose of 5 drops/day, one time daily for 5 days
Category
Treatment - Drugs
2
Description
Control group: Placebo drop orally at dose of 5 drops/day, one time daily for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abozar Hospital
Full name of responsible person
Dr. Azadeh Arefian
Street address
Tohid Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3444 9003
Email
itc@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
دکتر مهران حکیم زاده
Street address
Golestan street, Shahr Daneshgahi, Deputy of Research and Technology Development of Ahvaz Jondishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?