Fermented infant formula with prebiotics study.

Completed

• Conditions: Healthy term infants.

• Registration Number: NL-OMON25687
• Lead Sponsor: Danone Research - Centre for Specialised Nutrition

Brief Summary

1) Newly-developed Fermented Infant Formulas, Combining scGOS/lcFOS with Lactofidus, Show Equivalence of Weight Gain in Healthy Infants: A Randomized, Controlled, Double-blind, Multicenter, Intervention Study Vandenplas Y, Hourihane J, Bouritius H, Pennings B, Huet F, EAP 2013 <br><br> 2) A novel infant formula, combining scGOS/lcFOS with a specific fermented infant formula, shows lower incidence of colic in infants at 4 weeks of age compared to control formulas. Yvan Vandenplas, Hetty Bouritius, Thomas Ludwig, Frederic Huet, Jonathan Hourihane, ESPGHAN 2014 <br><br> 3) Associatoin of infantile colic with functional gastrointestinal disorder and symptoms.Vandenplas Y; Ludwig T; van Elburg R; Bouritius H; Huet F ESPGHAN 2015<br> 4)Partly Fermented Infant Formulae With Specific Oligosaccharides Support Adequate Infant Growth and Are Well-Tolerated. Huet F, Abrahamse-Berkeveld M, Tims S, Simeoni U, Beley G, Savagner C, Vandenplas Y, Hourihane JO. J Pediatr Gastroenterol Nutr.2016 Oct;63(4:e43-53

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 344

Inclusion Criteria

1. Healthy, term (gestational age ¡Ý 37 and ¡Ü 42 weeks) infants;

2. Birth weight between 2,5-4,5 kg. These data is derived from WHO growth curves to look at group between 10th and 90th percentile;

Exclusion Criteria

1. Breastfeeding;

2. Congenital condition and/or previous or current illness that could interfere with study;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight gain in grams per day from study entry until 17 weeks of age.

Secondary Outcome Measures

Name	Time	Method
Anthropometrics other than weight gain, gastrointestinal tolerance, crying, sleeping, stool characteristics, faecal parameters, safety, use of medication and nutritional supplements.