Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246010
Recruitment Status : Terminated (Very slow recruitment rate. Only 6 infants were recruited over 2 years.)
First Posted : September 22, 2014
Results First Posted : January 25, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mona Nabulsi, American University of Beirut Medical Center

Tracking Information
First Submitted Date  ICMJE September 18, 2014
First Posted Date  ICMJE September 22, 2014
Results First Submitted Date  ICMJE January 24, 2018
Results First Posted Date  ICMJE January 25, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
Diarrhea Duration [ Time Frame: From onset of illness till the day of last diarrheic stool passed. ]
number of days with 3 or more loose or watery stools
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2014)
Dirrhea duration [ Time Frame: 14 days ]
number of days with 3 or more loose or watery stools
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Weight Loss [ Time Frame: 7 days ]
    Percent weight loss from baseline
  • Illness Visits [ Time Frame: 7 days ]
    Number of participants with illness visits
  • Hospitalization Rate [ Time Frame: 7 days ]
    Rate of hospitalization
  • Parental Satisfaction [ Time Frame: 7 days ]
    Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2014)
  • Weight Loss [ Time Frame: 7 days ]
    Percent weight loss from baseline
  • illness visits [ Time Frame: 7 days ]
    Proportion with illness visit
  • Hospitalization Rate [ Time Frame: 7 days ]
    Rate of hospitalization
  • Parental Satisfaction [ Time Frame: 7 days ]
    Parental satisfaction with treatment
  • Illness severity [ Time Frame: 7 days ]
    Severity of symptoms assessed by a scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
Official Title  ICMJE Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
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.
Detailed Description Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Gastroenteritis
Intervention  ICMJE Dietary Supplement: Lactose- free milk
Lactose- free milk
Study Arms  ICMJE
  • Experimental: Lactose-free milk
    Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
    Intervention: Dietary Supplement: Lactose- free milk
  • No Intervention: Regular infant milk
    Regular infant milk formula and anti-diarrheic diet for 7 days.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 24, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2014)
40
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Exclusively or partially breast-fed infants
  • Severe dehydration requiring hospitalization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246010
Other Study ID Numbers  ICMJE PED.MN.09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mona Nabulsi, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account American University of Beirut Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP