Investigation of the impact of Bi2muno (Bi2GOS), a novel galacto-oligosaccharide mixture, on the composition of the infant faecal microbiota

ISRCTN	ISRCTN11961535
DOI	https://doi.org/10.1186/ISRCTN11961535
Secondary identifying numbers	N/A

Submission date: 03/01/2006
Registration date: 23/01/2006
Last edited: 19/02/2014

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anne McCartney
Scientific

School of Food Biosciences
The University of Reading
Whiteknights
PO Box 226
Reading
RG6 6AP
United Kingdom

Study information

Study design	Double-blind, randomised, placebo-controlled, parallel study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Other
Scientific title
Study objectives	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(s)	This study was approved in December 2005.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/02/2006
Completion date	01/04/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	A total of 30 healthy formula-fed infants
Key inclusion criteria	1. Signed consent form 2. Age at inclusion: 8-10 weeks 3. Fully formula fed infants
Key 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)
Date of first enrolment	01/02/2006
Date of final enrolment	01/04/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Food Biosciences

Reading
RG6 6AP
United Kingdom

Sponsor information

Clasado Ltd (UK)
Industry

11 Warren Yard
Wolverton Mill
Milton Keynes
MK12 5NW
United Kingdom

Website	http://www.clasado.com
"ROR"	https://ror.org/04e5xac72

Funders

Funder type

Industry

Clasado Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan