The study products will result in different stool consistency compared to reference product
ID
Bron
Verkorte titel
Aandoening
Stool consistency
Gastrointestinal (dis)comfort
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Stool consistency<br>
- Protein and fat digestion
Achtergrond van het onderzoek
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
Doel van het onderzoek
The study products will result in different stool consistency compared to reference product
Onderzoeksopzet
Baseline visit, week 4, 8, 12, and 16 (endline): anthropometry, diaries, questionnaires, stool samples
Onderzoeksproduct en/of interventie
Commercial available infant formula as a reference
Adapted infant formula I different processing
Adapted infant formula II different processing and different fat blend
Publiek
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
Wetenschappelijk
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5867 |
| NTR-old | NTR6291 |
| Ander register | FrieslandCampina : CETD00 |