No registrations found.
ID
Source
Brief title
Health condition
Healthy term infants.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight gain in grams per day from study entry until 17 weeks of age.
Secondary outcome
Anthropometrics other than weight gain, gastrointestinal tolerance, crying, sleeping, stool characteristics, faecal parameters, safety, use of medication and nutritional supplements.
Background summary
In 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.
Study objective
The 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).
Study design
The study will take 5 hospital visits and 1 phone call.
Intervention
Duration 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.
Manon Gadellaa
Wageningen 6700 CA
The Netherlands
+31 (0)317 467942
manon.gadellaa@danone.com
Manon Gadellaa
Wageningen 6700 CA
The Netherlands
+31 (0)317 467942
manon.gadellaa@danone.com
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;
3. Age ¡Ü 28 days;
4. Parents' or guardian's 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¡¯s 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2413 |
| NTR-old | NTR2521 |
| Other | Danone Research BV : Dig.1.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
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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
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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