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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

Not Applicable
Completed
Conditions
Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Registration Number
CTRI/2021/05/033685
Lead Sponsor
Dr Reddys Laboratories Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
54
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

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To measure the quantitative and qualitative differences in relative abundance of gut microbiota composition between Group I and Group II including: <br/ ><br>? Phyla Firmicutes and Bacteroidetes, Firmicutes/Bacteroidetes Ratio <br/ ><br>? Genera Lactobacillus, Bifidobacterium, Bacteroides, Prevotella, Enterobacter, Roseburia, Clostridium and Escherichia <br/ ><br>? Microbial diversityTimepoint: Day 0 to Day 5
Secondary Outcome Measures
NameTimeMethod
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
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