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

A Prospective, Multicenter, Open-Label, Randomized Control Study to Compare the Efficacy And Tolerability Of A Synbiotic Formulation (Gutnext®) and Single Probiotic (Enterogermina®-Bacillus Clausii Spores), In The Management Of Pediatric Diarrhea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019838
Enrollment
136
Registered
2019-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R197- Diarrhea, unspecified

Interventions

Intervention1: Synbiotic Formulation GUTNEXT®: Patients in the synbiotic group will be prescribed Gutnext® containing a combination of 4 probiotics (Saccharomyces boulardii 5 billion CFU + Lactobaci

Sponsors

Dr Vijay Yewale
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactMr Satrish Marukurthi

Dr. Yewale Multispecialty Hospial for Children

drvijay_y@apollohospitals.com9322243465

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026