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

Acute Diarrhea Clinical Trial

Official title:

Study of Nutritional Regime for Acute Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269892
• Other study ID #: ASD-1213-9
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2011
• Last updated: January 3, 2011
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: January 2009
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 14 Months

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• lactose-free milk
a milk without lactose
• conventional milk
a milk with lactose

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Isfahan university of medical sciences