Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults

Double-blind, Randomized, Placebo-controlled Trial of the Effects of Prophylactic Bifidobacterium Lactis HN019 Supplementation on the Incidence of Influenza Infection in Healthy Adults

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258842

Enrollment

426

Registered

2010-12-13

Start date

2010-12-31

Completion date

2011-05-31

Last updated

2010-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Prevention, Probiotic

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.

Interventions

DIETARY_SUPPLEMENTBifidobacterium lactis HN019

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

DIETARY_SUPPLEMENTPlacebo

Placebo sachet, consumed once per day for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Influenza infection	12 weeks	Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period

Secondary

Measure	Time frame	Description
Symptom duration	12 weeks	—
Symptom severity	12 weeks	—
Adverse event incidence	12 weeks	The proportion of subjects that reports at least one adverse event (regardless of cause) during the study

Countries

United States

Contacts

Primary ContactTisha Golden

tisha.golden@sprim.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026