Evaluation efficacy of montelukast in children gastroenteritis
Design
Clinical trial with control group and open label treatment on 60 patients
Settings and conduct
This study will be performed on 60 patients with diarrhea at Amirkola Children's Hospital- Babol. This study is open label.
All patients in the control group receive standard treatment includes serum therapy and zinc sulfate syrup. In the treatment group, in addition to the standard treatment of Montelukast, it is prescribed at a dose of 5 mg once a day for 14 days.
Before and at the end of the study, blood samples are taken from patients and serum is isolated. In the serum sample, the amount of interleukin-13 is measured with an ELISA kit. Clinical signs of diarrhea, number of times per day and abdominal pain will be recorded before and during treatment and at the end.
Participants/Inclusion and exclusion criteria
1. All patients with gastroenteritis, at any age 2 to 12 years and of both sexes, boys and girls are included in the study.
2. Patients with incurable disease or dangerous disease other than gastroenteritis.
3. Satisfaction of patients or their trustees (informed consent will be obtained from patients or patient trustees to participate in the study.)
Intervention groups
The control group is the group that receives routine treatment.
In addition to routine treatment, the treatment group also receives Montelukast.
Main outcome variables
Frequent diarrhea
Abdominal pain
General information
Reason for update
Acronym
MGE
IRCT registration information
IRCT registration number:IRCT20180624040213N3
Registration date:2022-02-01, 1400/11/12
Registration timing:registered_while_recruiting
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Hossein Najafzadehvarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3247 6421
Email address
h.najafzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation efficacy of montelukast in children gastroenteritis
Public title
Effect of montelukast in treatment of gastroenteritis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1. All patients with gastroenteritis, at any age 2 to 12 years and of both sexes, boys and girls are included in the study.
2. Patients with incurable disease or dangerous disease other than gastroenteritis.
3. Satisfaction of patients or their trustees (informed consent will be obtained from patients or patient trustees to participate in the study.)
Exclusion criteria:
Patients who develop a disease other than gastroenteritis during the study or find drug allergies
Refrain from collaborating with the research team during the study or refrain from taking medication and clinical examinations according to the study method.
Age
From 2 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Islamic Azad University, Ayatollah Amoli Branch
Street address
Mazandaran Babol Ayatollah Khamenei St. Ershad 15
City
Babol
Province
Mazandaran
Postal code
4719765574
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.IAU.AMOL.REC.1400.035
Health conditions studied
1
Description of health condition studied
Diarrhea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of serum interleukin level 13
Timepoint
Measurement of serum interleukin level 13 at the beginning of the study and 14 days after consumption of Montelukast
Method of measurement
Analysis of covariance (ANCOVA) will be used to evaluate the effect of montelukast on IL13 (before and after treatment) in both groups.
Secondary outcomes
1
Description
Frequency of diarrhea and abdominal pain in the study of the effectiveness of Montelukast in the treatment of pediatric gastroenteritis
Timepoint
Evaluation of abdominal pain and frequency of diarrhea and measurement of serum level of interleukin 13 at the beginning of the study and 14 days after taking Montelukast
Method of measurement
How to measure the frequency of diarrhea excretion according to Bristol criteria, Evaluation of abdominal pain based on criteria Visual Analogue
Intervention groups
1
Description
Control group: All patients in the control group receive standard gastroenteritis treatment. Routine treatment of gastroenteritis includes serum therapy and zinc sulfate syrup). Receive routine treatment (ORS and zinc) for 14 days.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to routine treatment (ORS and zinc), they receive Montelukast for 14 days. in the treatment group, Montelukast, is prescribed at a dose of 5 mg once a day for 14 days.