NCT01258842

Brief Summary

To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
426

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

December 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

December 9, 2010

Last Update Submit

December 10, 2010

Conditions

Influenza

Keywords

InfluenzaPreventionProbiotic

Outcome Measures

Primary Outcomes (1)

  • Influenza infection

    Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period

    12 weeks

Secondary Outcomes (3)

  • Symptom duration

    12 weeks

  • Symptom severity

    12 weeks

  • Adverse event incidence

    12 weeks

Study Arms (2)

B. lactis HN019

EXPERIMENTAL
Dietary Supplement: Bifidobacterium lactis HN019

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Bifidobacterium lactis HN019DIETARY_SUPPLEMENT

B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks

B. lactis HN019
PlaceboDIETARY_SUPPLEMENT

Placebo sachet, consumed once per day for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy free-living men and women aged 18 to 60 years
  • Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
  • Subject owns a refrigerator and is willing to keep study product refrigerated at all times
  • Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study, including possible risks and side effects
  • Consent to the study and willing to comply with study product and methods

You may not qualify if:

  • Influenza vaccination in last 6 months, or any other vaccination in previous 15 days
  • Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
  • Chronic nasal, laryngeal, pleural, or respiratory condition that could mimic or obscure symptoms of influenza (e.g. chronic allergic rhinitis, asthma, COPD, as determined by medical history and baseline physical examination)
  • Chronic use of medication(s) that could suppress or prevent flu-like symptoms (eg, antihistamines, cough medicines; echinacea, high-dose vitamin C)
  • Use of medication(s) within the previous 3 months that affect immune response (eg, antibiotics)
  • Contraindication to dairy products or any other substance in the study product (eg, lactose intolerance)
  • History of alcohol, drug, or medication abuse
  • Pregnant or lactating female, or pregnancy planned during study period
  • Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 3 months of screening
  • Participation in another study with any investigational product within 3 months of screening
  • Investigator believes that the participant may be uncooperative and/or noncompliant, and should therefore not participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

RECRUITING

Remedica, LLC

Rochester, Michigan, 48307, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Mario Clerici, MD

    Milano University Medical School

    PRINCIPAL INVESTIGATOR

  • Emilio Clementi

    University of Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tisha Golden

CONTACT

tisha.golden@sprim.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 13, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations

US(2)