evaluation of Gastro-fix powder efficacy in children with acute gastroenteritis
Design
This study is a double-blind controlled clinical trial.
Settings and conduct
In this study, patients who were diagnosed with acute gastroenteritis were admitted to Hazrat Masoumeh Salamullah Alaiha Hospital in Qom and were randomly divided into two groups receiving Gastrofix or placebo. Both groups will receive standard treatments.
Participants/Inclusion and exclusion criteria
Conditions for entering the study: formula feed children with acute gastroenteritis aged 6-24 months.
Conditions for not entering the study: children with bloody diarrhea, malnutrition, severe dehydration and patients with underlying diseases.
Intervention groups
160 patients with acute gastroenteritis will be randomized into two groups and receive one of the following interventions: 80 patients will receive Gastro-fix (9 g/kg daily, in three divided doses) and 80 other patients in the control group will receive regular formula as a placebo (9 g/kg daily, in three divided doses). All patients will receive standard treatments and usual care.
Main outcome variables
1. days of hospitalization
2. times of diarrhea per day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240508061709N1
Registration date:2024-05-12, 1403/02/23
Registration timing:prospective
Last update:2024-05-12, 1403/02/23
Update count:0
Registration date
2024-05-12, 1403/02/23
Registrant information
Name
Fahime Aalishavandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3296 0952
Email address
f.aalishavandi24@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Gastro-fix powder efficacy in pediatric acute gastroenteritis
Public title
Gastro-fix powder efficacy in pediatric acute gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
formula feed children with acute gastroenteritis aged 6 to 24 months
Exclusion criteria:
dysentery
chronic diarrhea
severe dehydration
malnutrition
underlying diseases (such as inflammatory bowel disease; necrotizing enterocolitis; immune deficiency, etc.)
Lack of parental consent
Age
From 6 months old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to two groups A (standard treatment + Gastro-Fix powder) or B (standard treatment + placebo powder) based on the pattern determined in the R software blockrand package. Random allocation will be done in decimal blocks to obtain groups of similar size. The sequence will be hidden until the patients are determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Special codes are assigned to patients and provided to therapists. Neither the patient nor the therapist knows whether the oral medicine that is given to the patient in addition to the standard treatment is Gastrofix powder or a placebo. Both drugs are made in powder form by Fasca Co.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Qom, Iran
City
Qom
Province
Ghoum
Postal code
3716154433
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUQ.REC.1403.029
Health conditions studied
1
Description of health condition studied
Gastroenteritis
ICD-10 code
A08.4
ICD-10 code description
Viral intestinal infection, unspecified
Primary outcomes
1
Description
length of hospitalization
Timepoint
after intervention
Method of measurement
Number of hospitalization days
2
Description
Frequency of diarrhea
Timepoint
after intervention
Method of measurement
Number
Secondary outcomes
1
Description
percentage of dehydration
Timepoint
Before and after the intervention
Method of measurement
The percentage of dehydration according to the dehydration scale of the World Health Organization
2
Description
stool consistency
Timepoint
before and after intervention
Method of measurement
stool consistency score
Intervention groups
1
Description
Intervention group: patients will receive Gastro-fix, 9 g/kg in three divided doses per day.
Category
Treatment - Other
2
Description
Control group: patients will receive regular formula 9 g/kg in three divided doses per day.