Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia L. Hibberd, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01274598
First received: January 3, 2011
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) in elderly subjects. 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:

  • LGG administered twice daily will be safe and well tolerated in elderly subjects
  • LGG will colonize the stool of elderly subjects and will modify the diversity and richness of the microbiota in their nasopharyngeal and stool specimens

Condition Intervention Phase
Healthy
Elderly
Biological: Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open Label Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Occurrence of adverse events that are possibly or probably related to administration of LGG [ Time Frame: through day 56 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Changes in the richness and bacterial diversity of the nasopharyngeal and gut microbiota and presence of LGG in stool specimens by routine culture [ Time Frame: through day 56 ] [ Designated as safety issue: No ]
    We will analyze the stool and nasopharyngeal samples to learn what bacteria are present during different phases of the study and how the types and quantities of bacteria may change over time.


Enrollment: 15
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)
Lactobacillus rhamnosus GG ATCC 53103 1 x 10^10 twice a day for 28 days
Biological: Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)
1x10^10 CFU by mouth twice daily for 28 days
Other Name: Culturelle

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 65-80 years
  2. Willing to complete the informed consent process
  3. Able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
  4. Willing to comply with protocol and report on compliance and side effects during the study period
  5. Informed consent obtained and signed prior to screening

Exclusion Criteria:

  1. 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.
  2. Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or antibiotics that may be used to treat LGG bacteremia or infection (i.e., subject able to tolerate at least 2 of the following regimens - Ampicillin or other beta lactam antibiotic, and Clindamycin, and Moxifloxacin).
  3. Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on the day of enrollment
  4. Drug or alcohol abuse within the previous 12 months
  5. Hospitalization, major surgery or endoscopy within the last 3 months
  6. Scheduled hospital admission within 3 months of enrollment
  7. Resident of a nursing home or rehabilitation center
  8. Presence of any of the following:

    • Grade 2 or higher abnormal vital signs or abnormalities on physical exam
    • Indwelling catheter or implanted hardware/prosthetic device or feeding tube
    • Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, history of gastrointestinal tract cancer or inflammatory bowel disease
    • History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease
    • Underlying structural heart disease such as abnormal native heart valve or congenital abnormality, previous history of endocarditis or valve replacement, Stage IV congestive heart failure
    • History of peripheral vascular disease or stroke
    • Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy, neutrophil count <500/mm3, or an anticipated drop in the neutrophil count to <500/mm3 or active or planned chemotherapy or radiotherapy
    • History of collagen vascular or autoimmune disease
    • End stage renal disease
    • History of chronic obstructive pulmonary disease or asthma
    • Diabetes or thyroid disease
    • Active TB
  9. Positive drug or alcohol testing at screening or positive breathalyzer at baseline or an unwillingness to undergo drug and alcohol testing
  10. Abnormal laboratory tests defined as any of the following:

    • White blood cell (WBC) < 3.3 or > 12.0 K/µL
    • Platelets < 125 K/µL
    • Hemoglobin Males: < 12.0 g/dL; Females: < 11.0 g/dL
    • Creatinine > 1.8 mg/dL
    • Blood urea nitrogen (BUN) >27 mg/dL
    • Aspartate aminotransferase (AST) > 1.25 ULN
    • Alanine aminotransferase (ALT) > 1.25 ULN
    • Alkaline phosphatase > 2.0 ULN
    • Bilirubin (total) > 1.5 ULN
    • Glucose (non-fasting ) >126 mg/dL
    • Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody
  11. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or would make it unlikely the subject could complete the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274598

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Patricia L Hibberd, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Patricia L. Hibberd, Chief, Division of Global Health; Department of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01274598     History of Changes
Other Study ID Numbers: U01AT002952-01A2
Study First Received: January 3, 2011
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Probiotics
Safety
Elderly
Lactobacillus
LGG

ClinicalTrials.gov processed this record on July 31, 2014