This study is a clinical trial on 60 formula-fed infants aged 2 months to 5 years hospitalized with acute watery diarrhea in pediatric ward of Shahid Beheshti hospital in 2014. Patients with bloody diarrhea, malnutrition and systemic diseases are excluded from the study. Patients randomly assign into two groups. Experimental group receive lactose-free formula and the control group will receive standard formula. In two groups, treatment protocols for watery acute diarrhea shall be conducted. Duration and frequency of diarrhea within the past 24 hours is recorded daily by asking mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051611145N7
Registration date:2014-05-21, 1393/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-21, 1393/02/31
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-11-11, 1393/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of lactose-free formula on acute watery diarrhea in infants consuming formula
Public title
The Effect of lactose-free formula on acute watery diarrhea in infants consuming formula
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Formula-fed infants hospitalized with acute watery diarrhea in pediatric ward of Shahid Beheshti hospital; Aged 6 months to 2 years.
Exclusion criteria: Bloody diarrhea; Malnutrition; Systemic diseases.
Age
From 6 months old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Approval date
2014-05-07, 1393/02/17
Ethics committee reference number
29/5/1/637/پ
Health conditions studied
1
Description of health condition studied
Acute Watery Diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Stop Diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
2
Description
Frequency of Diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
3
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Study of records & asking from mother
Secondary outcomes
1
Description
Admission period
Timepoint
At discharge
Method of measurement
Days recorded in dossier
Intervention groups
1
Description
Intervention: lactose-free formula
Category
Treatment - Drugs
2
Description
Control group: standard formula
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr.Mohammad Reza Sharif
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Sharif
Position
Associate Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
5th Kilometer Ravandi Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 9926
Fax
Email
mrsharifmd@yahoo.com
Web page address
www.drsharif.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Sharif
Position
Associate Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
5th Kilometer Ravandi Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
mrsharifmd@yahoo.com
Web page address
www.drsharif.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Sharif
Position
Associate Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
5th Kilometer Ravandi Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
mrsharifmd@yahoo.com
Web page address
www.drsharif.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)