No registrations found.
ID
Source
Brief title
Health condition
Stool consistency
Gastrointestinal (dis)comfort
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Stool consistency
- Protein and fat digestion
Secondary outcome
- Stool frequency
- Stool amount
- Stool color
- Gastrointestinal symptoms
- Crying time
- Fecal parameters
Background summary
Background:
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
Study objective
The study products will result in different stool consistency compared to reference product
Study design
Baseline visit, week 4, 8, 12, and 16 (endline): anthropometry, diaries, questionnaires, stool samples
Intervention
Commercial available infant formula as a reference
Adapted infant formula I different processing
Adapted infant formula II different processing and different fat blend
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
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)
Design
Recruitment
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 | NL5867 |
| NTR-old | NTR6291 |
| Other | FrieslandCampina : CETD00 |