A clinical study to check the effect medicine to control the Diarrhea in children.

Not Applicable

• Conditions: Health Condition 1: R197- Diarrhea, unspecified

• Registration Number: CTRI/2019/06/019838
• Lead Sponsor: Dr Vijay Yewale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Infants and pediatric patients of either sex in the age group of 3 months to 15 years.

2.Patients with the diagnosis of acute diarrhea (greater than 4 semi watery stools day) as per

Type 6 of Bristol stool scale.31

3. Diarrheal symptoms for at least one day and lasting up to less then and equal to 7 days.

4. Patient willing to participate in the study and sign an informed consent form.

Exclusion Criteria

1. Patients having chronic conditions (such as known chronic uncontrolled intestinal

disease such as coeliac disease cystic fibrosis food allergy immune deficiency inflammatory bowel disease gastrointestinal malformations abnormal gastrointestinal motility).

2. The presence of macroscopic blood in the faces.

3. Use of probiotic in the preceding 7 days.

4. Intractable vomiting (less than five successive times).

5. Known hypersensitivity to any of the ingredients of study medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the comparative efficacy of the synbiotic (Gutnext®) vs a single probiotic(Enterogermina® Bacillus clausii spores) in terms of duration of diarrhea in the pediatric populationTimepoint: To check the efficacy of drug in 5 days or 7 days.

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the comparative efficacy of the synbiotic (Gutnext®) vs. a single probiotic <br/ ><br>(Enterogermina® -Bacillus clausii spores) in terms of reduction in the daily frequency <br/ ><br>of diarrhea in the pediatric population. <br/ ><br>2. To evaluate the comparative tolerability of the synbiotic (Gutnext®) vs. a Single <br/ ><br>probiotic (Enterogermina® -Bacillus clausii spores) in pediatric patients with diarrhea.Timepoint: At 5 days