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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11961535

Enrollment

Registered

2006-01-23

Start date

2006-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant formula Nutritional, Metabolic, Endocrine

Interventions

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, ra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed consent form 2. Age at inclusion: 8-10 weeks 3. Fully formula fed infants

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026