A clinical trial to compare the effectiveness of Gasro-Fix and placebo (lactose free dried milk) on duration of diarrhea among children with acute gastroenteritis
(1) Objective: The aim of this study is to investigate the effectiveness of Gasro-Fix on duration of hospitalization among children with acute gastroenteritis. (2) Design: This study is a double blind randomized controlled trial (3) Setting and conduct: This study will be done at Karaj Shahid Bahonar educational and Therapeutic Center. Eligible subjects will randomly receive one of the following treatments; Gasro-Fix and placebo. (4) major eligibility criteria: This clinical trial will be carried out on 150 patients of both sex with acute gastroenteritis and being at the age of 6-60 months. (5) Intervention: 150 patients with acute gastroenteritis will be randomly assigned into two groups and will receive one of the following two interventions; 75 patients will receive Gasro-Fix (9g/kg, daily, in two to four divided doses per day) and 75 patients in control group will receive lactose-free formula as placebo (9g/kg, daily, in two to four divided doses per day). All patients will receive regular standard treatment and routine care throughout the study. (6) Main outcome measures: the primary outcome variable in the study is the length of hospitalization. The secondary outcome measures include the following: body weight, severity of diarrhea will be defined by the stool consistency score and frequency of diarrhea in 24 hours, the state of dehydration, using the World Health Organization's dehydration scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091536195N1
Registration date:2017-10-12, 1396/07/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Kumars Purrostami
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6009
Email address
kumarspurrostami@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of Gasro-Fix and placebo (lactose free dried milk) on duration of diarrhea among children with acute gastroenteritis
Public title
Effect of Gasro-Fix on children acute diarrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: child patients aged 6-60 months; diarrhea defined as the passage of three or more loose or liquid stools in 24 hours; diarrhea lasting at least 24 hours; and not exceeding two weeks from presentation of the disease; diarrhea with or without fever, vomiting, mucus in stool; Body weight more than 8 kg.
Exclusion criteria: acute diarrhea that contains blood; chronic diarrhea; severe dehydration; inflammatory bowel disease; necrotizing enterocolitis; immune deficiency; chronic disease and malnutrition.
Age
From 6 months old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
School of Medicine, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran.
City
Karaj
Postal code
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
Abzums.Rec. 1396.52
Health conditions studied
1
Description of health condition studied
gastroenteritis
ICD-10 code
A08.4
ICD-10 code description
Viral intestinal infection, unspecified
2
Description of health condition studied
gastroenteritis
ICD-10 code
A08.3
ICD-10 code description
Other viral enteritis
Primary outcomes
1
Description
length of hospitalization
Timepoint
after intervention
Method of measurement
Number of hospitalization days
Secondary outcomes
1
Description
body weight
Timepoint
befor and after intervention
Method of measurement
kg
2
Description
severity of diarrhea
Timepoint
befor and after intervention
Method of measurement
stool consistency score and frequency of diarrhea in 24 hours
3
Description
state of dehydration
Timepoint
befor and after intervention
Method of measurement
the state of dehydration, using the World Health Organization's dehydration scale
Intervention groups
1
Description
Intervention group: patients will receive Gasro-Fix, 9 g/kg in two to four divided doses per day.
Category
Treatment - Other
2
Description
Control group: patients will receive lactose-free formula 9 g/kg in two to four divided doses per day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Kumars Purrostami
Street address
Shora Blvd, Azimieh, Karaj, Alborz Province
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Alborz University of Medical Sciences
Full name of responsible person
Dr Mostfa Qorbani
Street address
Vice chancellor for research, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran.
City
Karaj
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 of Alborz University of Medical Sciences
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
Alborz University of Medical Sciences
Full name of responsible person
kumars Purrostami
Position
Medical Specialist
Other areas of specialty/work
Street address
School of Medicine, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran.
City
Karaj
Postal code
Phone
+98 26 3433 6009
Fax
Email
kumarspurrostami@abzums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
kumars Purrostami
Position
Medical Specialist
Other areas of specialty/work
Street address
School of Medicine, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran
City
Karaj
Postal code
Phone
+98 26 3433 6009
Fax
Email
kumarspurrostami@abzums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Kumars Purrostami
Position
Medical specialist
Other areas of specialty/work
Street address
School of Medicine, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran.
City
Karaj
Postal code
Phone
+98 26 3433 6009
Fax
Email
kumarspurrostami@abzums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)