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van CCT (UK)

van CCT (UK)

Gastrointestinal outcomes of different infant formulas

- candidate number26754
- NTR NumberNTR6344
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2017
- Secondary IDsLNCS00 FrieslandCampina
- Public TitleGastrointestinal outcomes of different infant formulas
- Scientific TitleCross-sectional study on gastrointestinal outcomes with different infant formulas
- hypothesisInfant formula with different macronutrient profile will result in improved gastrointestinal and stool characteristics
- Healt Condition(s) or Problem(s) studiedGastrointestinal characteristics, Stool
- Inclusion criteria- Term infants up to 4 months of age
- Normal birth weight of 2.5 to 4kg
- Exclusively formula fed
- Exclusion criteria- Infant on complimentary feeding
- Any congenital condition (previous/current) what could interfere with the study
- On any medication that could affect gastrointestinal symptoms and feeding
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 28-feb-2017
- planned closingdate15-apr-2017
- Target number of participants800
- InterventionsThe subjects are recruited according to their currently consumed formula and grouped accordingly. They will continue with their usual feeding practice and data will be collected over a period of one week
- Primary outcome- Stool characteristics such as consistency
- Gastrointestinal symptoms such as constipation
- Secondary outcome- Digestion metabolites and microbiota in stool
- TimepointsSubjects will fill in diary for 7 days and collect stool samples for 3 days. Data and samples will be collected after the one week study period
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Vanitha d/o Buthmanaban
- CONTACT for SCIENTIFIC QUERIES Vanitha d/o Buthmanaban
- Sponsor/Initiator Friesland Campina
- Funding
(Source(s) of Monetary or Material Support)
Friesland Campina
- Publications
- Brief summaryThe study aims to investigate the tolerance of commercially available infant formula in healthy term infants (0 to 4 months old) in China, using validated tools and stool sample analysis.
- Main changes (audit trail)
- RECORD24-feb-2017 - 1-jun-2017

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