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CTRI Number  CTRI/2024/04/065317 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective cohort study 
Study Design  Other 
Public Title of Study   Effect of mode of delivery on gut microbiota of Infants at BLDE, Bijapur 
Scientific Title of Study   Identifying gut microbiota diversity in children born through normal delivery and cesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Chandramouli 
Designation  Assistant Professor,Dept. of Biochemistry 
Affiliation  BLDE (Deemed to be University), Shri B.M.Patil Medical College,Hospital & Research Center 
Address  Dept. of Biochemistry, Smt. Bangaramma Sajjan Campus, Shri B M Patil Medical Collage, Vijaypura

Bijapur
KARNATAKA
586103
India 
Phone  9611825998  
Fax    
Email  rcm.reddy@bldedu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Chandramouli 
Designation  Assistant Professor, Dept. of Biochemistry 
Affiliation  BLDE (Deemed to be University), Shri B.M.Patil Medical College,Hospital & Research Center 
Address  Dept. of Biochemistry, Shri B.M.Patil Medical College,Hospital & Research Center, Smt. Bangaramma Sajjan Campus, BLDE (Deemed to be University)

Bijapur
KARNATAKA
586103
India 
Phone  9611825998  
Fax    
Email  rcm.reddy@bldedu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr R Chandramouli 
Designation  Assistant Professor, Dept. of Biochemistry 
Affiliation  BLDE (Deemed to be University), Shri B.M.Patil Medical College,Hospital & Research Center 
Address  Dept. of Biochemistry, Shri B.M.Patil Medical College,Hospital & Research Center, Smt. Bangaramma Sajjan Campus,BLDE (Deemed to be University)

Bijapur
KARNATAKA
586103
India 
Phone  9611825998  
Fax    
Email  rcm.reddy@bldedu.ac.in  
 
Source of Monetary or Material Support  
Shri B M Patil Medical Collage hospital and research centre,BLDE deemed to be university, Vijaypura 5086103 
 
Primary Sponsor  
Name  BLDE (Deemed to be University) Shri B.M.Patil Medical College,Hospital & Research Center 
Address  Smt. Bangaramma Sajjan Campus, B.M Patil Road ( Sholapur Road), Vijaypura - 586103 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Chandramouli  Shri B.M.Patil Medical College,Hospital & Research Center  Paediatrics OPD, Dept of Paediatrics , Shri B. M. Patil medical collage
Bijapur
KARNATAKA 
9611825998

chandramouli.reddy@bldedu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee, BLDE ( Deemed to be University ), Vijaypura  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gut microbiota analysis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  6.00 Month(s)
Gender  Both 
Details  40 Newborn babies will be included in the study.
Group A - 20 healthy infants delivered through caesarean section delivery
Group B - 20 healthy infants delivered through normal vaginal delivery. 
 
ExclusionCriteria 
Details  neonates whose mothers did not give concent
prematurely born infants
deliveries of unknown gestational age
infants with congenital anomalies or known genetic diseases
infants exposed to antibiotics in the first week of life
infants with breastfeeding difficulties or requiring food supplementation in the first three months
babies with known health conditions that may interfere with gut microbiota and immune function of the infant
mothers with known health conditions with known infectious decisions, congenital anomalies, metabolic diseases  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
gut microbiota Diversity measured as Alpha Diversity and Species and genus level differences will be measured  0 month
3 month
6 month 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction 

Newborns overall health and lifetime development are greatly influenced by their gut flora, which has an effect on their short- and long-term well-being. The immune system, mental health issues, and metabolic diseases have all been associated with abnormalities in gut microbiota, highlighting the critical role that gut microbiota plays in determining one’s quality of life. The gut microbiota functions as an extension of the host genome, containing 50-100 times more genes than the host and providing vital enzymes that the host is unable to manufacture. Many disorders can result from any changes in this microbial mix, known as dysbiosis.

The feeding schedule and mode of delivery are two examples of internal and external factors that have a significant impact on an infant’s gut microbiome health. Delivery methods such as vaginal and caesarean sections are crucial in determining the microbiological makeup. Because lactobacilli are so prevalent in the vagina, newborns delivered vaginally have higher than average quantities of these bacteria. On the other hand, babies born by caesarean section have lower microbe counts from the bacteroides genus.The composition of the gut microbiota is closely related to the immune system. Research has indicated that the gut microbiota plays a significant trole in controlling the immune system, and it has been linked to allergic and hypersensitive reactions via affecting the expression of the FOXP3 gene.So in this particular project we will be looking to decipher the effect of the mode of delivery on the gut microbiota diversity of the infant.


Objectives

To comprehend gut microbial diversity between neonates delivered vaginally and by caesarean section.

Study Design

A Prospective Cohort study.We will recruit healthy neonates delivered vaginally and by caesarean section at BLDE (DU)’s Shri B M Patil Medical Collage, Hospital & Research Centre, Vijayapura.During the first six months of their lives, we will monitor them and take stool sample three times: at birth (0 months), three months, and six months.


Study Protocol

Fecal samples from infant delivered after the 36 weeks gestation (0 months), after 03 months and 06 months will be collected in sterile containers and transported to the research laboratory either frozen (-20°C home freezer) or fresh (if collected within 4 hours) and after aliquoting they will be stored at -80°C until analysis.

Total DNA will be extracted using the Qiagen PowerSoil DNA Isolation Kit, Cat_12888100 and stored at -80°C until analysis.

Universal primers for the V4 region of the

16S IRNA gene will be used to amplify a 292 bp product that was sequenced on the Illumina MiSeq platform.

USEARCH software will be used to cluster paired-end reads into OTUs. The mothur software suite will be used to assign representative sequences to taxa in the SILVA v123 Nr99 taxonomic database.


Statistical Analysis

Alpha and beta diversity metrics will be compared between vaginal and caesarean-born infants at different time points using non-parametric tests (e.g., Kruskal-Wallis, Mann-Whitney U). Differential abundance analysis will be performed using appropriate statistical tests (e.g., DESeq2)



 
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