NCT00635388

Brief Summary

The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable healthy

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

February 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

February 19, 2008

Last Update Submit

October 15, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of healthy days.

    12 weeks

Study Arms (3)

1

SHAM COMPARATOR
Other: Placebo

2

EXPERIMENTAL
Other: Lactobacillus (Probiotic 1)

3

EXPERIMENTAL
Other: Lactobacillus and Bifidobacterium (Probiotic 2)

Interventions

PlaceboOTHER

oral, placebo, once/day for 12 weeks

1
Lactobacillus (Probiotic 1)OTHER

oral, Lactobacillus, once/day for 12 weeks

2
Lactobacillus and Bifidobacterium (Probiotic 2)OTHER

oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks

3

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be in good general health as reported by their parent(s)/legal guardian;
  • Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
  • Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)

You may not qualify if:

  • Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Cincinnati, Ohio, United States

Location

MeSH Terms

Interventions

Lacteol

Study Officials

  • Carl J Eastwood, MS

    Procter and Gamble

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 19, 2008

First Posted

March 13, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

US(1)