Study Stopped
Very slow recruitment rate. Only 6 infants were recruited over 2 years.
Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedResults Posted
Study results publicly available
January 25, 2019
CompletedFebruary 15, 2019
January 1, 2019
2 years
September 18, 2014
January 24, 2018
January 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diarrhea Duration
number of days with 3 or more loose or watery stools
From onset of illness till the day of last diarrheic stool passed.
Secondary Outcomes (4)
Weight Loss
7 days
Illness Visits
7 days
Hospitalization Rate
7 days
Parental Satisfaction
7 days
Study Arms (2)
Lactose-free milk
EXPERIMENTALLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Regular infant milk
NO INTERVENTIONRegular infant milk formula and anti-diarrheic diet for 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Infants on artificial milk formula
- Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center
- Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools).
You may not qualify if:
- Exclusively or partially breast-fed infants
- Severe dehydration requiring hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut Medical Center
Beirut, Lebanon
Related Publications (1)
Nabulsi M, Yazbeck N, Charafeddine F. Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:46. doi: 10.1186/s13063-015-0565-9.
PMID: 25771831DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mona Nabulsi
- Organization
- American University of Beirut
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Pediatrics
Study Record Dates
First Submitted
September 18, 2014
First Posted
September 22, 2014
Study Start
July 1, 2015
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
February 15, 2019
Results First Posted
January 25, 2019
Record last verified: 2019-01