Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine

NCT01368029 | Completed Phase 1 DMC

• 1 other identifier: 2010 P 001694
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or microorganism administered to confer "health benefits". Our research is focused on studying the possible therapeutic effects of LGG. The study hypotheses are:

1. 1.LGG or placebo administered twice daily will be safe and well tolerated in elderly subjects who have just received the trivalent inactivated influenza vaccine
2. 2.The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the influenza season will be higher in the LGG group than the placebo group
3. 3.The occurrence rate of influenza like illness during the influenza season will be lower in the LGG group than in the placebo group
4. 4.The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56 and at the end of the influenza season will be greater in the LGG group than the placebo group.

Conditions

Healthy; Elderly

Keywords

LGG; Immune response; Influenza vaccine; Elderly; Healthy; Microbiome

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events that are possibly or probably related to administration of LGG

  Adverse events will be detected during study visits with standardized questionnaires, medical history, vital signs, physical examinations, laboratory tests and review of subject diaries as well as between study visits on telephone calls based on responses to adverse event questionnaires. Additionally, subjects are encouraged to call the PI or study staff at any time if they are experiencing an adverse event.

  Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.

Secondary Outcomes (4)

• Anti-influenza systemic immune response

  Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.

• Anti-influenza mucosal immune response

  Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.

• Occurrence of influenza like illness

  Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.

• Changes in the richness and bacterial diversity of the nasopharyngeal and gut microbiota and presence of LGG in stool specimens by routine culture

  Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.

Study Arms (2)

LGG

EXPERIMENTAL

Lactobacillus rhamnosus GG (LGG) containing 1x10\^10 LGG per capsule will be given to volunteers with verbal and written instructions at the baseline visit. Capsules are to be taken orally twice a day on an outpatient basis.

Biological: Lactobacillus rhamnosus GG ATCC 53103 (LGG)

Placebo

PLACEBO COMPARATOR

Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis.

Biological: Placebo

Interventions

Lactobacillus rhamnosus GG ATCC 53103 (LGG) BIOLOGICAL

Study drug capsules (1x10\^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days

Also known as: Culturelle, LGG

LGG

Placebo BIOLOGICAL

Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-80 years
• Willing to complete the informed consent process
• Able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
• Is community dwelling for the past two years
• Has received routine physical in the past two years
• Has no new chronic conditions in the past two years
• Identifies a primary care clinician
• Has received recommended preventive services (Task Force for Clinical Preventive Services) for vaccination and cancer prevention/detection, e.g.:
• Pneumococcal vaccination
• Mammography
• Screening colonoscopy for cancer
• Willing to comply with protocol and report on compliance and side effects during the study period
• Informed consent obtained and signed prior to screening

You may not qualify if:

• Self-reported vaccination with influenza vaccine for the current season
• Vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period
• History of hypersensitivity to any influenza vaccine components including thimerosal or egg
• History of Guillain-Barre syndrome
• History of avoidance of egg and/or egg based products for any reason
• Acute febrile illness within the week prior to immunization - immunization deferred until illness resolved
• Consumption of supplements or food products containing LGG or probiotics for 28 days prior to the start of the study or consumption of yogurt that has the "live and active cultures" seal
• Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or antibiotics that may be used to treat LGG bacteremia or infection
• Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on the day of enrollment
• Drug or alcohol abuse within the previous 12 months
• Hospitalization, major surgery or endoscopy within the last 3 months
• Scheduled hospital admission within 3 months of enrollment
• Resident of a nursing home or rehabilitation center
• Presence of any of the following:
• Grade 2 or higher abnormal vital signs or abnormalities on physical exam

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Patricia L. Hibberd, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief; Division of Global Health; MGHfC

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 7, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (1)