“A randomised, double-blind, randomised controlled, parallel-group, multi-country study to investigate the effect of a partially hydrolysed infant formula with added synbiotics in gut microbiota composition and clinical effectiveness in infants at high risk of developing allergy.”
Official registration: https://clinicaltrials.gov/ct2/show/NCT03067714?term=NCT03067714&rank=1
To investigate the effect of a partially hydrolysed protein (pHP) infant formula with added synbiotics on gut microbiota composition and clinical effectiveness in infants at high risk of developing allergy.
Infants at risk of developing allergy (e.g. due to family history, C-section birth etc.) have been shown to have a dysbiosis of gut microbiota, which can affect the development of a healthy immune system and so increase their risk further.
The TEMPO study1 is a multi-country, randomised, double-blind, controlled, parallel group study to investigate the effect of a partially hydrolysed protein infant formula with added synbiotics on gut microbiota composition and clinical effectiveness in infants at high risk of developing allergy.
Enrollment started this year with the aim of recruiting 700 infants, 600 formula fed and 100 breastfed.
Parents/guardians of infants will be assigned to one of the randomised groups and requested to feed their infant with either:
- the study product: infant/follow-on formula with partially hydrolysed cows’ milk protein supplemented with synbiotics (prebiotics and probiotics, scGOS/lcFOS (9:1) and B.breve M-16V)
- the control product: standard infant formula/follow on formula with intact cow’s milk protein (and without the addition of synbiotics)
The study will start from the moment formula feeding started until the infant is 12 months of age. The study product is allowed to be combined with breastfeeding.
Stool samples will be taken at 17 weeks, 26 weeks, 39 weeks and 52 weeks and also 14 days the infant stops taking the product. Levels of Bifidobacterium and Clostridium cluster XIVa will be assessed and recorded. IgE-mediated allergic manifestations will also be recorded.
Countries: Netherlands, Belgium, Hungary, Chinese mainland Hong Kong and Taiwan, Israel, Italy, Singapore, Slovakia, Spain, Czech Republic, United Kingdom, Germany.