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CompletedNCT01215656Updated Oct 7, 2010

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

A Phase 2/3 interventional study of Lactobacillus fermentum and Follow on formula without probiotics in Incidence of Infectious Diseases, sponsored by Puleva Biotech. Completed. Open to participants aged 6 Months to 7 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-07.

Sponsored by Puleva Biotech · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
6 Months to 7 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Incidence of Infectious Diseases
03

In context

Communicable Diseases

4,453 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's enrollment of 188 is above the median of 122 across 2,719 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Puleva Biotech is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 7 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
188 participants (actual)

Study arms

  • Experimental
    Probiotic

    follow on formula with the probiotic Lactobacillus fermentum

    Dietary Supplement: Lactobacillus fermentum

  • Active comparator
    Control

    follow on formula without probiotics

    Dietary Supplement: Follow on formula without probiotics

Interventions

  • Dietary supplementLactobacillus fermentum
  • Dietary supplementFollow on formula without probiotics
06

What researchers measure

Primary outcomes

  1. Incidence of infectious diseases

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18. Erratum In: J Pediatr Gastroenterol Nutr. 2012 Apr;54(4):571. PubMed 21873895 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01215656
Lead sponsor
Puleva Biotech
First posted
Oct 6, 2010
Start date
May 2008
Primary completion
Jan 2010
Last update
Oct 7, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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