EnterocolitisPhase 4NCT00304863
Addition of Lactobacillus to Metronidazole in Treatment of CDAD
A Phase 4 study testing Lactobacillus GG in people with Enterocolitis and Pseudomembranous Colitis, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterocolitis, Pseudomembranous Colitis, Antibiotic-associated Colitis
- What is being tested?
- Lactobacillus GG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2008to 31 Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
Official title: Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
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.
- Being tested
- Lactobacillus GG
- Keywords
- CDAD, Clostridium difficile Associated Diarrhea
- Medical subject headings
- Enterocolitis, Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GGDrug
Also called Lactobacillus
This arm will receive the additional probiotic of lactobacillus GG
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | This are will not receive Lactobacillus |
| Arm 2 | Experimental | This arm will receive lactobacillus Receives: Drug: Lactobacillus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Treatment
the time to resolution of diarrhea caused by diarrhea
Measured: less than 10 days
Stool sample C. diff toxin assay
presence of C. diff toxin in stool after 30 days
Measured: 30 days after start of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study start1 Aug 2008 (estimated)
- Primary completion31 Jul 2010 (estimated)
- Study completion31 Jul 2010 (estimated)
Why it stopped: The assistant who was going to do this study moved to a different med center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Daniel M. Musher MD, Michael E. DeBakey VA Medical Center
- Investigators
- Daniel M Musher, M.D., Principal investigator, Baylor College of Medicine, Houston VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304863
- Sponsor's protocol ID
- H-17937
- Status last verified
- May 2017
- First submitted
- 16 Mar 2006
- Last updated
- 10 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
- ClinicalTrials.gov ID
- NCT00304863
- Acronym / sponsor ID
- H-17937
- Keywords
- CDAD, Clostridium difficile Associated Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The assistant who was going to do this study moved to a different med center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- 1 Aug 2008 (estimated)
- Primary completion
- 31 Jul 2010 (estimated)
- Study completion
- 31 Jul 2010 (estimated)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –This are will not receive Lactobacillus |
| Arm 2 | Experimental | Drug: Lactobacillus GGThis arm will receive lactobacillus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus GGAlso: LactobacillusThis arm will receive the additional probiotic of lactobacillus GG | Drug | Arm 2 |
Primary outcome
Response to Treatment
Time frame: less than 10 days
the time to resolution of diarrhea caused by diarrhea
Stool sample C. diff toxin assay
Time frame: 30 days after start of medication
presence of C. diff toxin in stool after 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
Related trials for Enterocolitis
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M Musher, M.D. principal investigator
Baylor College of Medicine, Houston VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus GG in people with Enterocolitis and Pseudomembranous Colitis, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to Treatment (time frame: less than 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.