Probiotics Administration Via Colonoscopic Spray and Oral Administration in CDAD Patients

Launched by NATIONAL CHENG-KUNG UNIVERSITY HOSPITAL · Mar 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with Clostridioides difficile (C. difficile) colitis, a serious infection that can cause severe diarrhea and is often acquired in hospitals. The research aims to see if delivering probiotics directly to the colon using a special spray during a colonoscopy is more effective than taking probiotics by mouth. All participants will receive standard treatment with oral vancomycin for 14 days, and then they will be randomly assigned to either receive the probiotics through a colonoscopic spray or take them orally over five days. The goal is to compare how these two methods affect the gut microbiota, which is the community of bacteria in the intestines, and to evaluate their safety and effectiveness.

To be eligible for this trial, participants must be at least 20 years old and diagnosed with C. difficile colitis. However, those with other types of colitis or certain medical conditions that make colonoscopy unsafe will not be included. If you join the study, you can expect to receive the standard treatment along with the assigned method of probiotic delivery, and you'll be monitored for how well the treatment works and any side effects. This trial is currently recruiting participants, and it hopes to find a potentially better treatment option for those suffering from this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients aged ≥ 20 years who are diagnosed with C. difficile colitis
• Exclusion Criteria:
• • patients are diagnosed with colitis because of other etiologies, such as intestinal Behçet's disease, amoeba or parasitic colitis, Salmonella colitis, lymphoma, E. coli colitis, cytomegalovirus colitis, ischemic colitis, sigmoid-colon cancer, inflammatory bowel diseases (ulcerative colitis or Crohn's disease), solitary rectal ulcer syndrome, radiation colitis
• • patients who have contraindications for colonoscopy, including declining or refusal to cooperate
• • unstable vital signs
• • a diagnosis or highly suspicion of colon rupture
• • a high-risk situation for colon perforation such as acute diverticulitis
• • toxic megacolon, etc.
• • acute myocardial infarct