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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161026030525N2

Enrollment

Registered

2020-09-13

Start date

2016-07-05

Completion date

Unknown

Last updated

2020-10-06

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

Conditions

Acute colitis. Other and unspecified gastroenteritis and colitis of infectious origin

Interventions

Intervention 1: Intervention group: Supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6

Eligibility

Sex/Gender

All

Age

3 Months to 14 Years

Inclusion criteria

Inclusion criteria: 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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMitra Ahmadi

Ahvaz University of Medical Sciences

ahmadi-mi@ajums.ac.ir+98 61 3444 3051

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026