Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
It is well established that formula-fed infants harbour a distinctive gastrointestinal (GI) microbiota (collection of bacteria indigenous to the infant gut) compared with those of breast-fed infants.
In general breast-fed infants' GI microbiota comprises predominately bifidobacteria, whilst formula-fed infants harbour a more diverse microbiota co-dominated by bacteroides, bifidobacteria and clostridia. Breast-feeding is, of course, considered the ''gold standard'' for infant nutrition. As well as supplying the necessary nutrients, breast milk confers numerous bioactive components, which afford protection of the infant (some of which may reflect the bifidobacterial predominance).
Indeed, breast-feeding is associated with reduced incidence of GI disorders (such as constipation, abdominal bloating and diarrhoea), compared with formula-feeding. Coupled with the recognized health and well-being associated with breast-fed infants, the predominance of the bifidobacterial group has generated a vast interest in improving this component of formula-fed infants' gut microbiota. Fortification of infant formulae with functional food supplements, namely probiotics (live microbial fed supplements) and prebiotics (substrates which selectively stimulate specific bacteria), has thus become a topic of particular interest.
The main objective for improving infant formulae is to better reflect the composition of breast-milk and to minimise the distinctions between breast-fed and formula-fed infants (physiological, microbiological and/or overall health status).
Ethics approval
This study was approved in December 2005.
Study design
Double-blind, randomised, placebo-controlled, parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Infant formula
Intervention
Bi2muno (Bi2GOS) 3 g versus Placebo (Maltodextrin 3 g)
Determine the effect of Bi2muno feeding (3 g/day) on the bifidobacterial component of formula-fed infants' faecal microbiota. A double-blind, randomised, placebo-controlled, parallel design 1-month feeding study will be performed using exclusively milk-fed infants aged 8 to 10 weeks, at inclusion. Faecal samples will be collected from soiled nappies of each individual on four separate occasions: 2 at baselines (i.e. prior to commencement of the trial) and 2 post-feeding. The bifidobacterial component of the faecal microbiota will be examined for all samples, both quantitatively (using Fluorescence <I>in situ</I> Hybridization [FISH]) and qualitatively (using Denaturing Gradient Gel Electrophoresis [DGGE], a molecular profiling technique). Comparisons will be made between baseline and post-feeding samples to identify changes in the bifidobacterial microbiota over time. Also, comparisons will be made between the two feeding groups to determine the effect of Bi2muno on bifidobacterial predominance and diversity.
Updated 19/02/2014: the trial was stopped due to poor recruitment.
Intervention type
Drug
Phase
Not Specified
Drug names
Bi2muno (Bi2GOS) 3 grams
Placebo (Maltodextrin 3 grams)
Primary outcome measure
To determine the effect of Bi2muno (Bi2GOS) 1 dose of 3 g/day on the bifidobacterial components (numbers and species diversity of the specific bacterial group) of formula-fed infants' faecal microbiota
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2006
Overall trial end date
01/04/2006
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Signed consent form
2. Age at inclusion: 8-10 weeks
3. Fully formula fed infants
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
A total of 30 healthy formula-fed infants
Participant exclusion criteria
1. Breast-fed infants
2. Infants with congenital abnormalities, or with proven suspected cow's milk allergy
3. Infants of multiple gestations
4. Infants who have received antibiotics less than two weeks before the start of the study
5. Infants fed any formula containing pro- or prebiotics
6. Infants with a history of gastrointestinal dysfunction (e.g. >5 bouts of diarrhoea)
Recruitment start date
01/02/2006
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Food Biosciences
Reading
RG6 6AP
United Kingdom
Sponsor information
Organisation
Clasado Ltd (UK)
Sponsor details
11 Warren Yard
Wolverton Mill
Milton Keynes
MK12 5NW
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Clasado Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list