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Antibiotics associated dysBbiosis in children

Role of Saccromyces Boullardi CNCMI 745 in prevention of antibiotic associated gut dysbiosis in 3 to 6 year old children double blinded placebo controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058339
Enrollment
200
Registered
2023-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

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

Interventions

Intervention1: SACHET SACCROMYCES BOULLARDII CNCMI 745: 1.Study group will be provided with 10 sachets each containing Sacchromyces Boulardii CNCM I 745 strain 250 mg after explaining the aims and obj

Sponsors

Dr Rachita Sewara
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
we will compared outcomes in both placebo and control groups (S. boulardii vs. placebo) on 6th day by assessing stool ph microscopy and bacterial loadTimepoint: on 6 day

Secondary

MeasureTime frame
Saccromyces boullardii CNCM I 745 play a role in prevention of antibiotic associated gut dysbiosisTimepoint: 6 DAYS

Countries

India

Contacts

Public ContactDr Anurag Singh

DR S.N. Medical College Jodhpur

singhjodhpur@gmail.com9414133692

Outcome results

None listed

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