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A Prospective study to determine gut microbiota composition in Indian children with history of antibiotic usage compared to those who did not use antibiotic by stool analysis

A Prospective, multi-centric, cohort study to determine gut microbiota composition in Indian children with history of antibiotic usage compared to those who did not by stool analysis using 16srRNA sequencing methods - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/05/033685
Enrollment
54
Registered
2021-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: A00-B99- Certain infectious and parasitic diseases

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group-I 1. Participants in the age group of 3 to 5 years with a diagnosis of infections and advised five days or more of oral or intravenous antibiotics 2. Parents willing to provide written informed consent Group-II 1. Participants In the age group of 3 to 5 years attending clinics for vaccination, non-infectious diseases. 2. Parents willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Group-I 1. Chronic illnesses including metabolic, neurological, allergic disorders 2. History of any other chronic illness, NICU & PICU admission 3. History of any acute childhood illness in the past week 4. History of drug intake in the last 3 months including antibiotics, PPIs, Probiotics Group-II 1. Chronic illnesses including metabolic, neurological, allergic disorders 2. History of any other chronic illness, NICU & PICU admission 3. History of any acute childhood illness in the past week 4. History of drug intake in the last 3 months including antibiotics, PPIs, Probiotics

Design outcomes

Primary

MeasureTime frame
To measure the quantitative and qualitative differences in relative abundance of gut microbiota composition between Group I and Group II including: ? Phyla Firmicutes and Bacteroidetes, Firmicutes/Bacteroidetes Ratio ? Genera Lactobacillus, Bifidobacterium, Bacteroides, Prevotella, Enterobacter, Roseburia, Clostridium and Escherichia ? Microbial diversityTimepoint: Day 0 to Day 5

Secondary

MeasureTime frame
To measure the biologic function of genera and species by analyzing stool samples using amplicon based 16s rRNA sequencing methodTimepoint: Day 0 to Day 5

Countries

India

Contacts

Public ContactColette Pinto

Dr. Reddys Laboratories Ltd.

krishnacv@drreddys.com7337341828

Outcome results

None listed

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