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Trial record 1 of 1 for:    NCT02246010
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Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country

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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

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.

Condition or disease Intervention/treatment Phase
Acute Gastroenteritis Dietary Supplement: Lactose- free milk Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactose-free milk
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Dietary Supplement: Lactose- free milk
Lactose- free milk

No Intervention: Regular infant milk
Regular infant milk formula and anti-diarrheic diet for 7 days.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: 7 days ]
    Percent weight loss from baseline

  2. Illness Visits [ Time Frame: 7 days ]
    Number of participants with illness visits

  3. Hospitalization Rate [ Time Frame: 7 days ]
    Rate of hospitalization

  4. Parental Satisfaction [ Time Frame: 7 days ]
    Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246010


Locations
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Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
  Study Documents (Full-Text)

Documents provided by Mona Nabulsi, American University of Beirut Medical Center:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mona Nabulsi, Professor of Clinical Pediatrics, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02246010     History of Changes
Other Study ID Numbers: PED.MN.09
First Posted: September 22, 2014    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: February 15, 2019
Last Verified: January 2019

Keywords provided by Mona Nabulsi, American University of Beirut Medical Center:
diarrhea
developing world
lactose-free diet
Clinical trial

Additional relevant MeSH terms:
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Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases