NCT00948051

Brief Summary

In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

Enrollment Period

1.8 years

First QC Date

July 27, 2009

Last Update Submit

April 12, 2011

Conditions

Infant

Outcome Measures

Primary Outcomes (1)

  • To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination

    1 month

Secondary Outcomes (1)

  • To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration

    1 month

Study Arms (2)

Fructo-oligosaccharides

EXPERIMENTAL
Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)

Interventions

Follow-on formula supplemented with fructo-oligosaccharidesDIETARY_SUPPLEMENT

Follow-on formula supplemented with fructo-oligosaccharides

Fructo-oligosaccharides
Follow-on formula enriched with placebo (maltodextrins)DIETARY_SUPPLEMENT

Follow-on formula enriched with placebo (maltodextrins)

Placebo

Eligibility Criteria

Age4 Months - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants aged of 4 months at randomization
  • not breast-fed infants

You may not qualify if:

  • infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria
  • infants suffering from a disease associated with gastro-intestinal disorder
  • infants who have taken antibiotic during the 2 months preceding randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Tormo

Barcelona, Spain

Location

MeSH Terms

Interventions

fructooligosaccharide

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 13, 2011

Record last verified: 2011-04

Locations

ES(1)