The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children

NCT01935986 | Terminated Phase 2

• 1 other identifier: U-12-032
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.

Conditions

Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• upper respiratory tract infections

  study period, 12 weeks

Study Arms (2)

probiotic

EXPERIMENTAL

dietary supplement

Dietary Supplement: probiotic

placebo

PLACEBO COMPARATOR

dietary supplement without probiotic

Dietary Supplement: placebo

Interventions

probiotic DIETARY_SUPPLEMENT

probiotic

placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy children

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

Foodfiles Sweden Ab

Uppsala, SE-751 83, Sweden

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 5, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-01

Locations

SE (1)