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A study to evaluate the effect of Lactobites bar in lactating women

A study to evaluate the effect of Lactobites bar as a galactagogue to increase the production of milk in lactating women - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/059959
Enrollment
50
Registered
2023-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lactobites Bar: 1 - 2 bars daily for 28 days. Control Intervention1: NA: NA

Sponsors

Nutrizoe Nutriifoods Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study included lactating women between 23 and 45 years old who have given birth to a healthy baby at term (born between 37 and 42 weeks) and those who have the perception of having a little volume of milk or nutritional composition of milk that is not adequate for their baby, women with 2 weeks of breastfeeding, and that at the time of beginning the study, they are not supplementing with formula milk for feeding their baby, they have the firm intention of breastfeeding for 28 more days.

Exclusion criteria

Exclusion criteria: participants suffering from any disease that may hinder or prevent breastfeeding, being currently consuming or having consumed in the two weeks prior to the study a probiotic or a supplement with plant extracts, being consuming any drug that can alter the volume or composition of breast milk, have an allergy to any antibiotics or peanuts, have an allergy to any of the components of the products under study.

Design outcomes

Primary

MeasureTime frame
Intensity of the clinical symptoms recorded during the study on Day 0, 14, 28 Duration of the clinical symptoms Patient Global Assessment and Physician Global Assessment will be assessed on day 28 Concomitant medications during the study period Timepoint: Day 0, 14, 28

Secondary

MeasureTime frame
Patient Global Assessment & Physician Global Assessment will be assessed on day 28 Concomitant medications during the study period Timepoint: Patient Global Assessment & Physician Global Assessment will be assessed on day 28

Countries

India

Contacts

Public ContactNikhil Datar

Cloud 9 Hospital Malad

drnikhil70@hotmail.com9837033335

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026