Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/01/2006
Date assigned
23/01/2006
Last edited
19/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anne McCartney

ORCID ID

Contact details

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

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 measures

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

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

http://www.clasado.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes