A clinical trial to study the safety of probiotics in infant formula

Phase 3

Completed

Registration Number: CTRI/2010/091/001111

Lead Sponsor: estec Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Healthy newborn infant who required supplemented/mixed feeding due to partial lactation failure or informed choice
2. Age at point of enrollment: less than 3 months of age
3. Gestational age ≥37 weeks and ≤42 weeks
4. Birth weight is ≥ 2?500 g and ≤ 4?500 g
5. Singleton birth
6. Mothers' education: minimum of 7 years of schooling
7. Parent/carer is expected to remain in the investigational site geographical area for the next 12 months
8. Having obtained the legal representative?s informed consent

Exclusion Criteria

1.Currently participating in another clinical trial
2.Infant from mother with diabetes during pregnancy
3.Infant from HIV positive mother
4.Congenital illness or malformation that may affect normal growth
5.Significant pre-natal and/or post-natal disease
6. Re-hospitalisation before inclusion in the study for more than 2 days for any reason except jaundice
7. Subject whose parent/carer cannot be expected to understand and to comply with feeding plan or instructions

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare growth pattern in terms of weight of starter formulas containing probiotics (Groups 1 and 2) with that of starter formula without probiotics (Group 3).Timepoint: six months of age

Secondary Outcome Measures

Name	Time	Method
?To compare growth patterns of groups 1 and 2 with group 3 in terms of body length, BMI and head circumferenceTimepoint: from enrollment until 12 months of age;To assess episodes and duration of diarrhea and respiratory infectionsTimepoint: From 1 month after enrollment until 12 months of age;To assess the gut micro flora composition (in a sub-group of infants)Timepoint: at 4.5 months of age;To assess the infants? digestive tolerance in the four groups up to 12 monthsTimepoint: From 1 month after enrollment until 12 months of age;To assess urinary d-lactate in a sub-group of infantsTimepoint: after 2 months of supplementation