NCT00304863

Brief Summary

The purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
2.4 years until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2010

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

March 16, 2006

Last Update Submit

May 9, 2017

Conditions

EnterocolitisPseudomembranous ColitisAntibiotic-associated Colitis

Keywords

CDADClostridium difficile Associated Diarrhea

Outcome Measures

Primary Outcomes (2)

  • Response to Treatment

    the time to resolution of diarrhea caused by diarrhea

    less than 10 days

  • Stool sample C. diff toxin assay

    presence of C. diff toxin in stool after 30 days

    30 days after start of medication

Study Arms (2)

Arm 1

NO INTERVENTION

This are will not receive Lactobacillus

Arm 2

EXPERIMENTAL

This arm will receive lactobacillus

Drug: Lactobacillus GG

Interventions

Lactobacillus GGDRUG

This arm will receive the additional probiotic of lactobacillus GG

Also known as: Lactobacillus
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin

You may not qualify if:

  • Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded.
  • Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

EnterocolitisEnterocolitis, Pseudomembranous

Interventions

Lacteol

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Daniel M Musher, M.D.

    Baylor College of Medicine, Houston VA Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 20, 2006

Study Start

August 1, 2008

Primary Completion

July 31, 2010

Study Completion

July 31, 2010

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)