Probiotics treatment for patients with C. difficile colitis
The Comparison of the Adjuvant Effect of Probiotics Between Delivery Via Colonoscopic Spray and Oral Administration in Patients With Clostridioides Difficile Colitis Receiving Vancomycin Treatment
This study is testing if giving probiotics directly into the colon works better than taking them by mouth for people with C. difficile colitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tainan, Other (Non U.s.)) |
| Trial ID | NCT05770726 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of probiotics administered via colonoscopic spray compared to oral administration in patients suffering from Clostridioides difficile colitis. The research aims to address the limitations of current treatments, such as prolonged oral vancomycin courses and the high cost of fidaxomicin. By evaluating the delivery method of probiotics, the study seeks to determine if colonoscopic administration can restore intestinal microbiota diversity more effectively than oral methods. The ultimate goal is to find a more accessible and effective treatment option for patients with refractory or recurrent C. difficile colitis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years and older diagnosed with C. difficile colitis.
Not a fit: Patients with colitis from other causes or those with contraindications for colonoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and accessible treatment option for patients suffering from recurrent C. difficile colitis.
How similar studies have performed: While probiotics have shown inconsistent efficacy in previous studies, this specific approach of comparing colonoscopic spray to oral administration is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tainan, Other (Non U.s.)
- National Cheng-Kung University Hospital — Tainan, Other (Non U.s.), Taiwan (Recruiting)
Study contacts
- Principal investigator: Hsueh-Chien Chiang, M.D. — National Cheng-Kung University Hospital
- Study coordinator: Hsueh-Chien Chiang, M.D.
- Email: scion456scion@gmail.com
- Phone: 2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.