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Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea

Study of Nutritional Regime for Acute Diarrhea

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01269892
Enrollment
74
Registered
2011-01-04
Start date
2009-01-31
Completion date
2009-08-31
Last updated
2011-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diarrhea

Keywords

diarrhea, lactose, milk, weight, acute.

Brief summary

The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.

Detailed description

Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.

Interventions

DIETARY_SUPPLEMENTlactose-free milk

a milk without lactose

DIETARY_SUPPLEMENTconventional milk

a milk with lactose

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to 14 Months
Healthy volunteers
Yes

Inclusion criteria

1. children with acute non-bloody diarrhea (≤ 2 weeks) 2. mild to moderate dehydration

Exclusion criteria

1. mucous bloody stools 2. major systemic illness 3. severe malnutrition (Weight for age \<60% and Weight for height \<70 %) 4. history of antibiotics receiving

Design outcomes

Primary

MeasureTime frameDescription
duration of diarrheaat seven days after admissionDuration of diarrhea corresponded to the time from enrollment to the cessation of diarrhea, which was defined as the passage of the last watery or loose stool before passage of two consecutive formed stools or no stool in a 24-hour period.

Secondary

MeasureTime frameDescription
changes in weight gainingat seven days after admissionnude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026