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Clinical Trials/CTRI/2025/07/091827
CTRI/2025/07/091827
Not yet recruiting
Phase 3 4

Efficacy of Supplementing Oral Probiotics to Breastfeeding Mothers on Neonatal Weight

K Manikandan Arunasalam1 site in 1 country102 target enrollmentStarted: August 11, 2025Last updated:
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Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
K Manikandan Arunasalam
Enrollment
102
Locations
1
Primary Endpoint
change in neonatal weight gain
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Day(s) to 1.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).

Outcomes

Primary Outcomes

change in neonatal weight gain

Time Frame: Baseline and 30 days.

Secondary Outcomes

  • To evaluate the effect of probiotics in preventing Neonatal Hyperbilirubinemia (NNH), and Necrotising Enterocolitis (NEC)(6 to 9 months)

Investigators

Sponsor
K Manikandan Arunasalam
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

K Manikandan Arunasalam

Chettinad Hospital and Research Institute

Study Sites (1)

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