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Colonoscopic Probiotics Spray in Irritable Bowel Syndrome

NCT05864716 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-07-31

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is a common chronic functional disorder of the gastrointestinal (GI) tract characterized by chronic abdominal pain and altered bowel habits without organic disease. IBS is associated with substantial costs to patients, healthcare system and society in terms of increased health care expenditures, loss of work productivity and decrease in quality of life (QoL). Multiple factors play an important role in the pathogenesis of IBS, including disturbed gut microbiota (dysbiosis). Fecal microbiota transplantation (FMT) and probiotics administration can manipulate the disturbed intestinal microbiota. According to previous studies, inconsistent efficacy of oral probiotic administration was reported. FMT may have good and lasting efficacy, but the donor selection and route of administration are still issues. Direct delivery of probiotics into the colon by colonoscopy can ensure sufficient microbiota distribution in the colon, so faster and better efficacy may be expected. Therefore, this study is aimed toward validating the efficacy and safety of the colonoscopic probiotics-spray in IBS treatment.

Patients diagnosed with irritable bowel syndrome by Rome IV criteria will be enrolled in this randomized double-blind double-dummy parallel controlled study. The 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 followed by oral placebo for 5 days, while the patients in the PO group will receive colonoscopic spray of placebo once followed by oral probiotics divided into 5 days. Then all of the patients will take the same dose of oral probiotics until 4 weeks. This study will evaluate the efficacy between the PS group and the PO group. Moreover, this study will compare the difference in fecal microbiota changes and safety between these two groups.

Conditions

  • Effect of Drug

Interventions

BIOLOGICAL

Colonscopic probiotics spray

20g of multi-strain probiotics powder via colonoscopic spray. The probiotic used in this study is SynPro-15G, which has 15 probiotics, including Bacillus coagulans BC1031, Bifidobacterium bifidum BB14, Bifidobacterium breve BR18, Bifidobacterium animalis subsp. lactis BAL06, Bifidobacterium longum (B. longum) BL986, Lactobacillus acidophilus LA1063, Lactobacillus casei LC122, Lactobacillus delbrueckii subsp. lactis LDL114, Lactobacillus fermentum LF26, Lactobacillus helveticus LH43, Lactobacillus paracasei LPC12, Lactobacillus plantarum LP198, Lactobacillus reuteri LR21, Lactobacillus rhamnosus LRH10, and Streptococcus thermophilus ST37 at a concentration of 2x1010 CFU/g (Synbiotech Corp., Kaohsiung, Taiwan). SynPro-15G is made either as a vial of powder (2x1011 CFU /vial) for colonoscopic spray or as a capsule (2x1010 CFU/capsule) for oral intake.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-04-30
Completion
2026-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864716 on ClinicalTrials.gov