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

NCT01274598 | Completed Phase 1 DMC

• 1 other identifier: U01AT002952-01A2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Elderly

Keywords

Probiotics; Safety; Elderly; Lactobacillus; LGG

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.

  through day 56

Secondary Outcomes (1)

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

  through day 56

Study Arms (1)

Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)

EXPERIMENTAL

Lactobacillus rhamnosus GG ATCC 53103 1 x 10\^10 twice a day for 28 days

Biological: Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)

Interventions

Lactobacillus Rhamnosus GG, ATCC 53103 (LGG) BIOLOGICAL

1x10\^10 CFU by mouth twice daily for 28 days

Also known as: Culturelle

Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)

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
• 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:

• 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 (i.e., subject able to tolerate at least 2 of the following regimens - Ampicillin or other beta lactam antibiotic, and Clindamycin, and Moxifloxacin).
• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Solano-Aguilar G, Molokin A, Botelho C, Fiorino AM, Vinyard B, Li R, Chen C, Urban J Jr, Dawson H, Andreyeva I, Haverkamp M, Hibberd PL. Transcriptomic Profile of Whole Blood Cells from Elderly Subjects Fed Probiotic Bacteria Lactobacillus rhamnosus GG ATCC 53103 (LGG) in a Phase I Open Label Study. PLoS One. 2016 Feb 9;11(2):e0147426. doi: 10.1371/journal.pone.0147426. eCollection 2016.

  PMID: 26859761 DERIVED

• Hibberd PL, Kleimola L, Fiorino AM, Botelho C, Haverkamp M, Andreyeva I, Poutsiaka D, Fraser C, Solano-Aguilar G, Snydman DR. No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. PLoS One. 2014 Dec 1;9(12):e113456. doi: 10.1371/journal.pone.0113456. eCollection 2014.

  PMID: 25438151 DERIVED

Study Officials

• Patricia L Hibberd, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Global Health; Department of Pediatrics

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 11, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (1)