| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
ObjectivesTo comprehend gut microbial diversity between neonates delivered vaginally and by caesarean section.Study DesignA 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 ProtocolFecal 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 the16S 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 AnalysisAlpha 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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