Immune Response to C.Difficile Infection

Status Recruiting

Clinical Trial Summary

The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by identifying how a Th 17 response impacts severity of C. difficile infection and how Type II immunity protects the gut from Clostridium difficile toxin-induced damage. This could lead to new and effective approaches to the treatment or prevention of Clostridium difficile colitis that act downstream of fecal microbiota transplants (FMT) or next generation probiotics. Successful fecal microbial transplantation will restore protective immunity to recurrent C.difficile infection.

Clinical Trial Description

The study includes one cohort of hospitalized patients with acute CDI who may require diagnostic colonoscopy, a second cohort of outpatients with recurrent CDI scheduled for FMT and a third cohort of inpatients with past history of CDI without recurrence. Blood samples and discarded stool samples for research will be obtained from adult hospitalized patients. Biopsies and brushing samples for research will be obtained from patients requiring diagnostic colonoscopies for clinical care. Follow-up will include phone contact at 60-90 days to determine relapse or mortality in acute CDI patients. Blood and colonic biopsies and brushing samples will be obtained from patients undergoing FMT for recurrent CDI and again after 60 days from convalescent patients. Blood and biopsies taken for research purposes at each colonoscopy will be analyzed for: cytokines and chemokines, gene expression analysis, immunohistochemistry and high dimensional flow-cytometry. ;

Study Design

Related Conditions & MeSH terms

Clostridium Difficile

Clinical Trial Details

NCT number	NCT02797288
Study type	Observational
Source	University of Virginia
Contact	William A. Petri, MD,PhD
Phone	434-924-5621
Email	wap3g@virginia.edu
Status	Recruiting
Phase
Start date	March 22, 2017
Completion date	January 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02896244` - AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Recruiting	`NCT06071312` - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach	Phase 1/Phase 2
Recruiting	`NCT01973465` - Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis	N/A
Terminated	`NCT01048567` - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly	Phase 2
Completed	`NCT01066221` - Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile	N/A
Not yet recruiting	`NCT03586206` - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Completed	`NCT02563106` - A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI	Phase 2
Completed	`NCT02857582` - Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile	Phase 2
Completed	`NCT02207140` - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly	Phase 0
Not yet recruiting	`NCT01942447` - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis	N/A
Active, not recruiting	`NCT01703494` - Fecal Transplant for Relapsing C. Difficile Infection	Phase 2
Completed	`NCT01813500` - Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients	N/A
Completed	`NCT01087892` - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection	N/A
Suspended	`NCT00591357` - Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy	Phase 4
Recruiting	`NCT00377078` - Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.	N/A
Completed	`NCT02254967` - A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population	Phase 4
Terminated	`NCT01775397` - A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System	Phase 4
Terminated	`NCT03617172` - PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol	Phase 2
Recruiting	`NCT05622721` - REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Completed	`NCT02437487` - SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)	Phase 2