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NCT01274598 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy and Elderly, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT01274598: Completed Phase 1 study of Healthy and Elderly, sponsored by Massachusetts General Hospital.

NCT01274598 is a Phase 1 study of Healthy and Elderly that has completed, run by Massachusetts General Hospital. The registered enrollment target is 15 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01274598, a Phase 1 study of Healthy and Elderly, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BIOLOGICAL Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-12
Est. Completion 2011-08
Phase Phase 1

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01274598

The ClinicalTrials.gov registry entry for NCT01274598 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Lactobacillus Rhamnosus GG, ATCC 53103 (LGG) is the first listed.

NCT01274598 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01274598 about?

NCT01274598 is a clinical study titled "Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Elderly Subjects". 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 "...

What is the current status of trial NCT01274598?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-12. Estimated completion is 2011-08.

What conditions does trial NCT01274598 study?

This clinical trial studies the following conditions: Healthy, Elderly.

What interventions are being tested in trial NCT01274598?

The interventions under investigation include: Lactobacillus Rhamnosus GG, ATCC 53103 (LGG) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01274598?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01274598 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.