| CTRI Number |
CTRI/2025/07/091827 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Supplementing Oral Probiotics in Breastfeeding Mothers on Neonatal Weight |
|
Scientific Title of Study
|
Efficacy of Supplementing Oral Probiotics to Breastfeeding Mothers on Neonatal Weight |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Manikandan Arunasalam |
| Designation |
PG Student |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Postnatal ward and OPD Department of Paediatrics Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam
Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9894883024 |
| Fax |
|
| Email |
arunasalam17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaishree vasudevan |
| Designation |
professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Postnatal ward and OPD Department of Paediatrics Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam
Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9444362134 |
| Fax |
|
| Email |
vsdvnjshr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaishree vasudevan |
| Designation |
professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Postnatal ward and OPD Department of Paediatrics Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam
Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9444362134 |
| Fax |
|
| Email |
vsdvnjshr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K Manikandan Arunasalam |
| Address |
Chettinad Hospital and Research Institute Rajiv Gandhi salai OMR kelambakkam Chennai Tamilnadu India 603103 |
| Type of Sponsor |
Other [self] |
|
|
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 K Manikandan Arunasalam |
Chettinad Hospital and Research institute |
Postnatal ward and OPD Department of paediatrics CHRI rajiv gandhi salai OMR kelambakkam chennai tamilnadu India 603103
Chennai
TAMIL NADU |
9894883024
arunasalam17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CARE Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal newborn |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
multistrain probiotic supplementation |
multistrain probiotic supplementation to breastfeeding mothers as once daily dosing for a duration of 30 days |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
Healthy breastfeeding mothers (aged 18 to 40 years) of Full term neonates with a birth weight of more than or equal to 2.5 kg.
Exclusive breastfeeding commitment for at least one months.
|
|
| ExclusionCriteria |
| Details |
Maternal antibiotic use within the last two weeks.
Preterm neonates or those with congenital anomalies.
Mothers with significant medical conditions (e.g., diabetes, hypothyroid, autoimmune diseases).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in neonatal weight gain |
Baseline and 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of probiotics in preventing Neonatal Hyperbilirubinemia (NNH), and Necrotising Enterocolitis (NEC) |
6 to 9 months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="0"
Months="9"
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
|
Maternal probiotic supplementation during lactation significantly enhances neonatal weight gain in the early postnatal period. This intervention is a safe, non-invasive, and potentially cost-effective strategy to promote optimal growth in exclusively breastfed infants. Further large-scale studies are needed to confirm these findings and evaluate long-term outcomes. |