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Study on the effects of an infant formula on stool in healthy infants


- candidate number26812
- NTR NumberNTR6291
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2017
- Secondary IDsCETD00 FrieslandCampina
- Public TitleStudy on the effects of an infant formula on stool in healthy infants
- Scientific TitleA controlled, randomized, double-blind nutritional study to assess the effects of milk processing and fat blend composition on stool consistency and protein and fat digestion in infants
- ACRONYMCONDOR
- hypothesisThe study products will result in different stool consistency compared to reference product
- Healt Condition(s) or Problem(s) studiedGastrointestinal disease
- Inclusion criteria- Healthy and term infants (gestational age >= 37 and <= 42 weeks)
- Infants who are partially formula fed (> 500 mL formula/day) or exclusively formula fed
- At least 30 infants per arm (n=90 in total) are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding for at least 1 week before inclusion)
- Birth weight between 2.5 and 4.5 kg
- Age < 40 days
- Exclusion criteria- Congenital condition and/or previous or current illness that could interfere with study
- Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
- Having a mother suffering from diabetes during pregnancy
- Participation in another clinical trial
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements (including to fill in the diaries and to wait with introducing weaning foods until 4 months of age)
- Use of antibiotics at the time of screening, or during the past two weeks
- Being one of multiple birth (i.e. twins, triplets)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-jul-2018
- Target number of participants300
- InterventionsCommercial available infant formula as a reference
Adapted infant formula I different processing
Adapted infant formula II different processing and different fat blend
- Primary outcome- Stool consistency
- Protein and fat digestion
- Secondary outcome- Stool frequency
- Stool amount
- Stool color
- Gastrointestinal symptoms
- Crying time
- Fecal parameters
- TimepointsBaseline visit, week 4, 8, 12, and 16 (endline): anthropometry, diaries, questionnaires, stool samples
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES I.M.S. Tan-Khouw
- CONTACT for SCIENTIFIC QUERIES I.M.S. Tan-Khouw
- Sponsor/Initiator Friesland Campina
- Funding
(Source(s) of Monetary or Material Support)
FrieslandCampina
- Publications
- Brief summaryBackground:
Around 55% of infants <6 months of age suffer from gastrointestinal problems. Especially, passing of hard stools, which can lead to constipation, cramps and crying, is a concern. As digestive discomfort is associated with problems in digestion of proteins and lipids, the quality of the diet is an important factor.
Objective:
To improve fat and protein absorption and prevent digestive problems in infants this study aims to assess effects of processing of infant formula and milk fat on stool consistency and digestion related outcomes.
Study Design:
Randomized double blind reference control parallel study with three arms: 1) alternative processing, 2) alternative processing + milk fat, 3) reference formula
- Main changes (audit trail)
- RECORD3-mrt-2017 - 14-mei-2017


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