Efficacy of oral probiotic in reducing of duration of diarrhea in children with acute colitis: a double blind randomized placebo controlled trial

Phase 1

Conditions: Acute colitis.
Other and unspecified gastroenteritis and colitis of infectious origin
A09.0

Registration Number: IRCT20161026030525N2

Lead Sponsor: Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 94

Inclusion Criteria

Patients 3 months to 14 years of age admitted to the hospital due to acute infectious colitis.
Patients with fever and watery stools more than 3 times a day and less than 14 days after the onset of the disease
Dysentery or the presence of more than 5 WBCs and any number of RBCs in the stool test

Exclusion Criteria

Immunodeficiency
Severe abdominal distension
Severe infection or sepsis
History of gastrointestinal surgery
Use of antibiotics or probiotics in the last two weeks
Patients who have been hospitalized due to oral intolerance or lack of response to treatment The need for antibiotics other than azithromycin.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Day.

Secondary Outcome Measures

Name	Time	Method
Frequency of diarrhea. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Number of times of diarrhea per day.;Duration of vomiting. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Number of days the patient vomits.;Frequent vomiting. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Number of times of vomiting per day.;Body temperature. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Maximum temperature every 24 hours.;Duration of hospitalization. Timepoint: End of hospitalization. Method of measurement: Number of days the patient is hospitalized.