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Fermented infant formula with prebiotics study.


- candidate number8467
- NTR NumberNTR2521
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-sep-2010
- Secondary IDsDig.1.C/A Danone Research BV
- Public TitleFermented infant formula with prebiotics study.
- Scientific TitleA randomised, controlled, double-blind, equivalence trial to test growth with and tolerance of new infant formulae in healthy, term infants.
- ACRONYMFIPS
- hypothesisThe mean weight gain of healthy infants receiving the study formula(s) during the first months of life is equivalent to the mean weight gain of healthy infants receiving the control formula(s).
- Healt Condition(s) or Problem(s) studiedEarly feeding , Health
- Inclusion criteria1. Healthy, term (gestational age °› 37 and °‹ 42 weeks) infants;
2. Birth weight within normal range for gestational age and sex (10th to 90th percentile according to locally applicable growth charts);
3. Age °‹ 28 days;
4. Parents' or guardian's written informed consent.
- Exclusion criteria1. Breastfeeding more than once daily;
2. Congenital condition and/or previous or current illness that could interfere with study;
3. Known or increased risk of cow's milk allergy, soy allergy and/or lactose intolerance (i.e. one of the biological parents diagnosed with asthma, hay fever, nasal allergy, eczema, skin allergy, and/or food allergy);
4. Having a mother suffering from diabetes during pregnancy;
5. Participation in another clinical trial;
6. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-sep-2010
- planned closingdate31-mrt-2012
- Target number of participants344
- InterventionsDuration of intervention: 15-19 weeks;
1. Intervention groups: Cow's milk-based fermented infant formulae with prebiotics (combination of two pre-existing products which stimulate digestion);
2. Control groups: Cow's milk-based fermented/non-fermented infant formulae with/without prebiotics.
- Primary outcomeWeight gain in grams per day from study entry until 17 weeks of age.
- Secondary outcomeAnthropometrics other than weight gain, gastrointestinal tolerance, crying, sleeping, stool characteristics, faecal parameters, safety, use of medication and nutritional supplements.
- TimepointsThe study will take 5 hospital visits and 1 phone call.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. Manon Gadellaa
- CONTACT for SCIENTIFIC QUERIESMSc. Manon Gadellaa
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- Publications1) 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

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

3) Associatoin of infantile colic with functional gastrointestinal disorder and symptoms.Vandenplas Y; Ludwig T; van Elburg R; Bouritius H; Huet F ESPGHAN 2015
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
- Brief summaryIn this study, new infant formulae combining the above ingredients will be tested with respect to growth and tolerance in healthy term infants. For the participants the study will last 15-19 weeks, including 5 hospital visits and 1 phone call.

At this first visit, baseline data are collected. Further study visits are conducted at 4, 8, 13, and 17 weeks of age. At each visit, data on growth are collected. Parents will be asked to record data on tolerance in the 7-day period prior to the study visits. Moreover, stool samples are collected either during or directly after the first visit, and just before the final visit. Two weeks after the final visit, a follow-up phone call takes place.
- Main changes (audit trail)19-Feb-2013: Changes in inclusion- and exclusion criteria - NM
Inclusion criteria:
1. Healthy, term (gestational age °› 37 and °‹ 42 weeks) infants;
2. Birth weight between 2,5 ®C 4,5 kg. These data is derived from WHO growth curves to look at group between 10th and 90th percentile;
3. Age °‹ 28 days;
4. Parents°Į or guardian°Įs, aged °›18 years, written informed consent.
Exclusion criteria:
1. Breastfeeding;
2. Congenital condition and/or previous or current illness that could interfere with study;
3. Known or increased risk of cow°Įs milk allergy, soy allergy and/or lactose intolerance;
4. Having a mother suffering from diabetes during pregnancy;
5. Participation in another clinical trial;
6. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
- RECORD17-sep-2010 - 12-okt-2016


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