NCT01269892

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2009

Enrollment Period

7 months

First QC Date

January 3, 2011

Last Update Submit

January 3, 2011

Conditions

Acute Diarrhea

Keywords

diarrhea, lactose, milk, weight, acute.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • changes in weight gaining

    at seven days after admission

Study Arms (2)

lactose-free milk

OTHER

it is kind of nutritional regime

Dietary Supplement: lactose-free milk

conventional milk

OTHER

it is kind of nutritional regime

Dietary Supplement: conventional milk

Interventions

lactose-free milkDIETARY_SUPPLEMENT

a milk without lactose

Also known as: nothing
lactose-free milk
conventional milkDIETARY_SUPPLEMENT

a milk with lactose

Also known as: nothing
conventional milk

Eligibility Criteria

Age3 Months - 14 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

DiarrheaBody Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Gholamrezaei, MD

    MD,research comittee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 4, 2011

Record last verified: 2009-01

Locations

IR(1)