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Effect of Azithromyacin on Microbiome And Growth in Infants (A-MAGI)

The Effect of Intrapartum Azithromycin on the Trajectory of Infant Growth & Gut Microbiome Development - A-MAGI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037525
Enrollment
300
Registered
2021-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O269- Pregnancy related conditions, unspecified

Interventions

None listed

Sponsors

The National Institutes of Diabetes and Digestive and Kidney Disorders NIDDK
Lead Sponsor
Boston University School of Public Health
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: � Mother must be a participant in the A-PLUS trial � Infant must be enrolled prior to discharge from the hospital after delivery � Family must be planning to remain in the Nagpur area for the next 12 months

Exclusion criteria

Exclusion criteria: � Infants with multiple congenital anomalies (e.g., cyanotic congenital heart disease, spina bifida, or other nervous system malformations) will be excluded.

Design outcomes

Primary

MeasureTime frame
Infant length (length-for-age z-score)Timepoint: at 24-hrs, 1-week, 6-weeks and 3, 6, 9 and 12 months

Secondary

MeasureTime frame
Outcome TimePoints � Additional growth indicators (weight-for-age and weight-for-length z-scores, middle-upper-arm-circumference and head circumference)Timepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months;� Antibiotic levels in women�s breastmilkTimepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months;� Infant GI microbiome indicators (alpha diversity, beta diversity, relative abundance of different taxa, metabolic capacity)Timepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months;� Maternal breastmilk and aereolar skin microbiome indicators (alpha diversity, beta diversity, relative abundance of different taxa)Timepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months

Countries

India

Contacts

Public ContactDr Archana Patel India

Lata Medical Research Foundation

dr_apatel@yahoo.com07122249569

Outcome results

None listed

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