Probiotics Administration Via Colonoscopic Spray and Oral Administration in CDAD Patients

NCT05770726 | Unknown

• 1 other identifier: B-BR-111-052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Clostridioides difficile (C. difficile) colitis is a common hospital-acquired disease, which increases hospitalization length and the mortality rate. Moreover, refractory or recurrent C. difficile colitis is an emerging disease. The tapering course of oral vancomycin or oral fidaxomicin is current standard treatment for refractory or recurrent C. difficile colitis. Fecal microbiota transplantation (FMT) is an alternative one. However, the tapering course of oral vancomycin needs a 6- to 12-week duration, fidaxomicin is expensive, and FMT is not available in every hospital; therefore, it is needed to develop a new treatment. Evidence has shown that the disturbance with reduced diversity of intestinal microbiota may lead to refractory C. difficile colitis. Besides fecal microbiota transplantation, probiotics administration can also correct the disturbed intestinal microbiota. However, inconsistent efficacy of probiotic administration was reported, which may be attributed to the interference by the gastric acid. Precise delivery of probiotics into the colon by colonoscopy can avoid the destruction by gastric acid, with which a better treatment efficacy is expected. The best regimen for C. difficile colitis should be the one which succeeds on the first attempt. Therefore, this study is aimed toward validating the efficacy and safety of the colonoscopic probiotics-spray. Patients diagnosed with C. colitis will be enrolled. All patients will accept the standard treatment of oral vancomycin for 14 days. As an adjuvant probiotic administration at the same time, enrolled patients will be randomly assigned to the probiotics-spray (PS) group and the probiotics-oral (PO) group, respectively. The patients in the PS group will receive colonoscopic spray of probiotics once, while the patients in the PO group will receive the same dosage of oral probiotics divided into 5 days. This study will compare the difference in fecal microbiota changes between the colonoscopic probiotics-spray group and the probiotics-oral group. Moreover, this study will evaluate the efficacy and safety between the colonoscopic probiotics-spray and probiotics-oral in patients with C. difficile colitis.

Conditions

Diarrhea Infectious

Keywords

Clostridioides difficile colitis

Outcome Measures

Primary Outcomes (1)

• The percentage of difference in fecal microbiota change, including probiotics, between the colonoscopic probiotics-spray and probiotics-oral and before and after probiotics use either by colonoscopic probiotics-spray or probiotics-oral

  All patients will be monitored for 30 days after diagnosis of C. difficile colitis. The primary endpoint is the comparison of the perseverance of fecal microbiota and metabolites. We will compare the microbiota by sequencing 16S rRNA, measured as percentage abundance per microbial species and differences in percentage abundance between the PS group and PO group in Day 0 and Day 5. We will also compare the relative abundance of C. difficile and target probiotics between the two study groups, such as Lactobacillus acidophilus, Bifidobacterium bifidum, Streptococcus thermophilus, or others.

  5 days

Secondary Outcomes (5)

• The rate of resolution of C. difficile colitis

  30 days

• Hospitalization length

  30 days

• The rate of recurrence of C. difficile colitis

  30 days

• The rate of mortality events

  30 days

• The rate of adverse events

  30 days

Study Arms (2)

probiotics-spray (PS) group

ACTIVE COMPARATOR

In the PS group, the colonoscopic prescription of 10 grams of probiotics powder is performed once on one of the first three days (D0-D3).

Dietary Supplement: Probiotics administration

probiotics-oral (PO) group

ACTIVE COMPARATOR

In the PO group, we will prescribe oral probiotics 2 capsules once per day for 5 days (a total of 10 grams) as adjunctive treatment during the first five days (D0-D4).

Dietary Supplement: Probiotics administration

Interventions

Probiotics administration DIETARY_SUPPLEMENT

A total of 10 grams of probiotics was administered in both group, but the routes were different. One group were per colonoscopic spray, and the other was per oral.

probiotics-oral (PO) group; probiotics-spray (PS) group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥ 20 years who are diagnosed with C. difficile colitis

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Other (Non U.s.), 704, Taiwan

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Dysentery

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Hsueh-Chien Chiang, M.D.

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsueh-Chien Chiang, M.D.

CONTACT

2353535; scion456scion@gmail.com

Hsiu-Chi Cheng, Ph.D

CONTACT

2353535; teishuki@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 15, 2023
• Study Start: April 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-01

Locations

TW (1)