Clinical trials: Pseudomembranous Colitis
Fulminant Clostridium Difficile Colitis
Loop Ileostomy With Colonic Lavage for Fulminant Clostridium Difficile Colitis
LAY SUMMARY Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe illness.
- Trial name
- NCT02347280
- Testing
- Loop Ileostomy with colonic lavage, Total Abdominal Colectomy with end ileostomy
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Jewish General Hospital
Crohn Disease, Ulcerative Colitis
Safety and Efficacy of Fecal Microbiota Transplantation
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease…
- Conditions
- Crohn Disease, Ulcerative Colitis, Celiac Disease, Irritable Bowel Syndrome
- Trial name
- NCT04014413
- Testing
- Fecal Microbiota Transplantation
- Where
- Hong Kong
- Volunteers
- 450 people
- Sponsor
- Chinese University of Hong Kong
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Antibiotics Associated Colitis, Pulmonary Infection
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients.
- Trial name
- NCT01058356
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Pharmbio Korea Co., Ltd.
Enterocolitis, Pseudomembranous, Diarrhea
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C.
- Conditions
- Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile
- Trial name
- NCT00466635
- Testing
- GT267-004 (tolevamer potassium sodium)
- Where
- 13 sites in United States
- Volunteers
- 65 people
- Sponsor
- Genzyme, a Sanofi Company
Diarrhea
C. Difficile and Ursodiol
In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence.
- Trial name
- NCT02748616
- Testing
- Ursodiol
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- NYU Langone Health
Clostridium Difficile Associated Diarrhea
A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis
Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C.
- Trial name
- NCT01559545
- Testing
- Metronidazole, Metronidazole-DRF1, Metronidazole-DRF2
- Where
- 12 sites in India
- Volunteers
- 60 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Clostridium Difficile Infection, Diarrhea
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.
- Trial name
- NCT01230957
- Testing
- Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant)
- Where
- 30 sites in United States
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Clostridium Difficile, Colitis
The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers
The investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for…
- Trial name
- NCT02063282
- Where
- Israel
- Volunteers
- 394 people
- Sponsor
- Amos Yinnon
Clostridium Difficile Colitis
Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection
The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children.
- Trial name
- NCT01972334
- Testing
- FMT
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- MemorialCare Health System
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Pseudomembranous Colitis, Clostridium Difficile Diarrhea
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD).
- Conditions
- Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
- Trial name
- NCT00382304
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 8 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile
Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis
This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected…
- Trial name
- NCT01973465
- Testing
- Stool
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- OSF Healthcare System
Clostridioides Difficile Infection, Clostridium Difficile Infection
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident…
- Conditions
- Clostridioides Difficile Infection, Clostridium Difficile Infection, Clostridium Difficile Diarrhea, Clostridia Difficile Colitis
- Trial name
- ACT (NCT04305769)
- Testing
- Alanyl-glutamine
- Where
- 2 sites in United States
- Volunteers
- 260 people
- Sponsor
- University of Virginia
Clostridia Difficile Colitis
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides…
- Trial name
- TAPER-V2 (NCT07328971)
- Testing
- Fidaxomicin, Vancomycin capsule
- Where
- 2 sites in Canada
- Volunteers
- 500 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Clostridium Difficile Colitis
Phase I Trial of a Single Dose of CRS3123
Double-blind, randomized, placebo-controlled Phase I Trial to determine the safety and pharmokinetics of a single dose of CRS3123 in healthy adult volunteers.
- Trial name
- NCT01551004
- Testing
- CRS3123
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Post-COVID-19 Condition, Ulcerative Colitis
Emerging Indications for Hyperbaric Oxygen Treatment
This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric…
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis
- Trial name
- NCT07240649
- Testing
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Volunteers
- 100 people
- Sponsor
- Jay C. Buckey Jr.
Clostridium Enterocolitis, Pseudomembranous Colitis
Response of Clostridium Difficile Infection to Metronidazole Therapy
In this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.
- Conditions
- Clostridium Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis
- Trial name
- NCT00304369
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- Michael E. DeBakey VA Medical Center
Clostridium Difficile Colitis
Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe
Once the lab test is positive for c. diff, the investigators will order the patient to have PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not clear 2 more liters may be ordered.
- Trial name
- COLITIS (NCT01630096)
- Testing
- Nu-Lytely
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Ascension Health