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Clostridium Infections clinical trials

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NCT ID: NCT03647995 Terminated - Clinical trials for Diarrhea, Clostridium Difficile

Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea.

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to determine the efficacy of probiotics containing 25Bn (billion) CFU (colony-forming unit) of Lactobacillus rhamnosus, Sacchromyces boulardii and Bifidobacterium breve in the prevention of antibiotic induced diarrhea and Clostridium difficile diarrhea. The chosen population consists of 190 hospitalized patients taking antibiotics. Preselected and randomized patients will take probiotics once daily until 1 week after the course of antibiotic is over or a placebo with 0 CFU. The primary outcome is to detect the occurrence of an antibiotic-associated diarrhea. The secondary outcome is to assess the presence of Clostridium difficile toxins in stool culture.

NCT ID: NCT03617172 Terminated - Clinical trials for Clostridium Difficile

PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol

PROCLAIM
Start date: November 26, 2018
Phase: Phase 2
Study type: Interventional

A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites. The total study time period for study procedures followed by clinical monitoring is anticipated to be about 24 months (biomarker assays and other analyses may be completed after the 24 month time period). All participants will receive oral antibiotics for CDI under the care of their physician. After consenting to participate in the study, participants will be randomized to receive either misoprostol (200 mcg po BID) or matching placebo for 14 days. Participants will be monitored for a total time-period of approximately 9 weeks with the goal of monitoring for recurrence of CDI during an 8-week follow-up period from the time that the course of antibiotic treatment is completed. Patients will have blood and stool samples (or rectal swabs if participants are unable to provide a stool sample) collected throughout the study to assess adherence, biomarkers, and to confirm recurrence of CDI (if necessary).

NCT ID: NCT03548051 Terminated - Dysbiosis Clinical Trials

Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)

Start date: January 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be randomized at each site to receive either FMT by enema or placebo by enema in a 2:1 ratio. Study duration is 3 years, subject participation duration is approximately 1 year. The primary study objectives are: 1) to evaluate the safety of FMT(s) delivered by enema vs. placebo delivered by enema and 2) to determine efficacy of FMT delivered by enema vs. placebo delivered by enema.

NCT ID: NCT03298048 Terminated - Clinical trials for Recurrent C. Difficile Infection

Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)

Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection

NCT ID: NCT03200093 Terminated - Clinical trials for Clostridium Difficile Infection

Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Start date: June 8, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium difficile for hospitalized patients receiving systemic antibiotic therapy. Half of participants will receive oral vancomycin daily, while the other half will receive a placebo.

NCT ID: NCT03105479 Terminated - Clinical trials for Clostridium Difficile Infection

Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

Start date: April 14, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.

NCT ID: NCT03065374 Terminated - Clinical trials for Clostridium Difficile Infection

Treatment for Clostridium-difficile Infection With IMM529

Start date: September 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.

NCT ID: NCT03005379 Terminated - Clinical trials for Clostridium Difficile Infection

Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

MATCH
Start date: November 15, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.

NCT ID: NCT02730325 Terminated - Clinical trials for Clostridium Difficile

To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients

Start date: December 2015
Phase: N/A
Study type: Interventional

The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations: I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are receiving vancomycin. II. Hospitalized UC patients who tested negative for C. difficile at time of admission.

NCT ID: NCT02707198 Terminated - Diarrhea Clinical Trials

Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir

Start date: November 2015
Phase: Phase 2
Study type: Interventional

This study is being conducted to investigate the potential benefits of probiotic intake for preventing antibiotic associated diarrhea and Clostridium difficile infection in patients undergoing a systemic antibiotic treatment. The primary research question is: can daily intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea and Clostridium difficile infection in patients during antibiotic treatment?