Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01215656

Enrollment

188

Registered

2010-10-06

Start date

2008-05-31

Completion date

Unknown

Last updated

2010-10-07

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

Conditions

Incidence of Infectious Diseases

Brief summary

The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.

Interventions

DIETARY_SUPPLEMENTLactobacillus fermentum

DIETARY_SUPPLEMENTFollow on formula without probiotics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 7 Months

Healthy volunteers

Yes

Inclusion criteria

* 6 months old children born at term * written consent from parents

Exclusion criteria

* frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux) * gastrointestinal surgery * cow's milk protein allergy * metabolic diseases (diabetes or lactose intolerance) * immune deficiency * antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)

Design outcomes

Primary

Measure	Time frame
Incidence of infectious diseases	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026