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

Growth of infants who are supplementary fed / mixed fed with probiotics-containing formula in India

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001111

Enrollment

400

Registered

2010-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Probiotics: From 0 to 6 months of age: Group 1: Lactobacillus reuteri, av intake 1x10E8 CFU/Day // Group2: Bifidobacteria lactis: av intake 1x10E8 CFU/day /// From 7 to 12 months of age

Eligibility

Inclusion criteria

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 &#8805;37 weeks and &#8804;42 weeks 4. Birth weight is &#8805; 2?500 g and &#8804; 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
? 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	—

Measure

Time frame

? 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

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Countries

India

Contacts

Public ContactSanjeev Ganguly, MD, Nestle Nutrition

Nestle India Ltd

Sanjeev.Ganguly@IN.nestle.com+91 12 4238 9300

Outcome results