WithdrawnPhase 4

Addition of Lactobacillus to Metronidazole in Treatment of CDAD

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

United States0Started 2008-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response to Treatment

Timeframe: less than 10 days

Stool sample C. diff toxin assay

Timeframe: 30 days after start of medication

Trial details

NCT IDNCT00304863

SponsorMichael E. DeBakey VA Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2010-07-31

View on ClinicalTrials.gov More Enterocolitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.