Antibiotics associated dysBbiosis in childre

Phase 4

Conditions: Health Condition 1: J00- Acute nasopharyngitis [common cold]

Registration Number: CTRI/2023/10/058339

Lead Sponsor: Dr Rachita Sewara

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

The present Double-blind, randomised, placebo-controlled clinical trial will be carried out after approval by the ethics committee of Dr. S. N. Medical College, Jodhpur and subjects will enrolled after written informed consent.

Children attending Paediatric clinic of or are admitted in the paediatrics wards of UMAID /MDM hospital Jodhpur (Rajasthan) and who are prescribed Antibiotics for respiratory illness and otitis media will be recruited for the current study.

Exclusion Criteria

children having any clinical evidence of:

1. Known chronic or recurrent systemic disorder associated with immunocompromised.

2. A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer’s or baker’s yeast, Amoxicillin-Clavulanate, amoxicillin or other penicillins, or cephalosporins.

3. Prior gastrointestinal surgery.

4. Known and diagnosed cases of Celiac disease.

5. Diagnosed case of Cystic fibrosis.

6. Structural GI diseases include strictures, stenosis, hemorrhoids, diverticular disease, colon polyps, colon cancer and inflammatory bowel disease.

7. Oral or systemic antibacterial therapy during the 3 months prior to study enrolment.

8. Prescription, over-the-counter medications or supplements that are known to alter gut function or microflora (i.e., acid anti-secretory drugs, probiotics) during the 4 weeks prior to study enrolment.

9. Chronic or persistent diarrhoea (12 weeks) or severe diarrhoea, i.e. diarrhoea managed with intravenous fluids or requiring hospital admission.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
we will <br/ ><br>compared outcomes in both placebo and control groups <br/ ><br>(S. boulardii vs. placebo) on 6th day by assessing stool ph microscopy and bacterial loadTimepoint: on 6 day

Secondary Outcome Measures