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

Study of Nutritional Regime for Acute Diarrhea

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

Study Overview

• Status: Completed
• Conditions: Acute Diarrhea
• Intervention / Treatment: Dietary supplement: lactose-free milk; Dietary supplement: conventional milk

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Al-Zahra University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: lactose-free milk; it is kind of nutritional regime	Dietary supplement: lactose-free milk; a milk without lactose; Other Names: nothing
Other: conventional milk; it is kind of nutritional regime	Dietary supplement: conventional milk; a milk with lactose; Other Names: nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of diarrhea	Duration 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.	at seven days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in weight gaining	nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission	at seven days after admission

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Study Chair: Ali Gholamrezaei, MD, MD,research comittee

Publications and helpful links

Helpful Links

• Isfahan university of medical sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Estimate): January 4, 2011
• Last Update Submitted That Met QC Criteria: January 3, 2011
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: diarrhea, lactose, milk, weight, acute.
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: ASD-1213-9