WithdrawnNCT00304863Updated May 10, 2017

Addition of Lactobacillus to Metronidazole in Treatment of CDAD

A Phase 4 interventional study of Lactobacillus GG in Enterocolitis, Pseudomembranous Colitis and Antibiotic-associated Colitis, sponsored by Michael E. DeBakey VA Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-10.

Primary conditionEnterocolitis, PseudomembranousRegistry: EnterocolitisReclassifiedWhy we changed it

Registry

Enterocolitis — the first condition term the registry derived for this study.

ClinicalTrials.gg

Enterocolitis, Pseudomembranous

Why

The study's listed conditions name Enterocolitis, Pseudomembranous, a narrower term within Enterocolitis.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Michael E. DeBakey VA Medical Center · Phase 4, Interventional, and Treatment

Why this study was withdrawn

The assistant who was going to do this study moved to a different med center

Phase: Phase 4
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

Clostridium difficile associated disease (CDAD), which nearly always follows antibiotic therapy, has become increasingly common and important in American hospitals, causing substantial morbidity and mortality. Metronidazole is the recommended treatment for this condition. We have recently reported (Clin Infect Dis, June 2005) that treatment with metronidazole is associated with a 22% rate of failure and 28% rate of relapse. No other medication has been shown to be more effective. There is a substantial theory and some limited data to suggest that dietary supplementation with non-pathogenic normal bowel bacteria will benefit these patients. Lactobacillus GG is the best-standardized and the most extensively studied of these agents.

Conditions studied

Enterocolitis
Pseudomembranous Colitis
Antibiotic-associated Colitis

Browse trials for

Enterocolitis 21Registry's first term
Enterocolitis, Pseudomembranous 43Primary · reclassified

Keywords

CDAD
Clostridium difficile Associated Diarrhea

In context

Enterocolitis, Pseudomembranous Reclassified

43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.

Browse Enterocolitis, Pseudomembranous studies →

Lead sponsor

Michael E. DeBakey VA Medical Center is the lead sponsor of 27 studies on the registry; none are open to participants now.

Compared within Enterocolitis, Pseudomembranous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Enterocolitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Single (Participant)
Enrollment: 0 participants (actual)

Study arms

No intervention
Arm 1
This are will not receive Lactobacillus
Experimental
Arm 2
This arm will receive lactobacillus
Drug: Lactobacillus GG

Interventions

DrugLactobacillus GG
This arm will receive the additional probiotic of lactobacillus GG
Also known as: Lactobacillus

What researchers measure

Primary outcomes

Response to Treatment
the time to resolution of diarrhea caused by diarrhea
Time frame: less than 10 days
Stool sample C. diff toxin assay
presence of C. diff toxin in stool after 30 days
Time frame: 30 days after start of medication

Study locations

1 site

Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas 77030, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2008; primary completion for Jul 2010, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 16, 2006
First posted: Mar 20, 2006
StartEst.: Aug 1, 2008
Primary completionEst.: Jul 31, 2010
CompletionEst.: Jul 31, 2010
Last update: May 10, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00304863
Lead sponsor: Michael E. DeBakey VA Medical Center
Collaborators: Baylor College of Medicine
Responsible party: Daniel M. Musher MD (Principle Investigator, Michael E. DeBakey VA Medical Center) — Principal investigator
First posted: Mar 20, 2006
Start date: Aug 1, 2008 (estimated)
Primary completion: Jul 31, 2010 (estimated)
Completion: Jul 31, 2010 (estimated)
Last update: May 10, 2017

Study contacts

Daniel M Musher, M.D.

principal investigator · Baylor College of Medicine, Houston VA Medical Center

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Lacticaseibacillus rhamnosus GG

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Michael E. DeBakey VA Medical Center

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