Colonoscopic Probiotics Spray in Irritable Bowel Syndrome

NCT05864716 | Not Yet Recruiting

• 1 other identifier: A BR 111 0 47
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Irritable bowel syndrome; Probiotics; Colonoscopic spray

Outcome Measures

Primary Outcomes (1)

• A change in the IBS-SSS total score of ≥50 points

  The primary endpoint is a reduction in the IBS-SSS total score of ≥50 points .Abdominal symptoms are assessed on Day 0, Day 5, Day 28 and Day 84 using the IBS-SSS questionnaires. Patients whose total IBS- SSS score decreased by ≥50 points after the intervention are considered responders. A decrease of ≥175 points in the IBS- SSS total score considered to indicate significant clinical improvements.

  84 days

Secondary Outcomes (4)

• The preservation of probiotics following intervention

  28 days

• The change of fecal microbiota following intervention

  28 days

• A reduction in the Hospital Anxiety and Depression Scale (HADS)

  84 days

• A reduction in Fatigue Assessment Scale (FAS)

  84 days

Study Arms (2)

probiotics-spray (PS) group

EXPERIMENTAL

In the PS group, 1 vial of multi-strain probiotics powder via colonoscopic spray is performed once, followed by five-days of two oral placebo capsules daily. After the five-day treatment, the 2nd fecal sample will be collected. Both groups will receive a 23-day course of oral probiotics (two capsules twice daily) subsequently. The patients were asked to keep a diary to record bowel habits and register any adverse events. The 3rd fecal sample will be collected 28 days after the colonoscopy. The questionnaires will be completed 28 days and 84 days after the colonoscopy to assess responses of treatment. Polyethylene glycol and loperamide were allowed during the intervention as the rescue medication.

Biological: Colonscopic probiotics spray

probiotics-oral (PO) group

ACTIVE COMPARATOR

In the PO group, 1 vial of placebo powder via colonoscopic spray is performed once, followed by five-days of two oral probiotics capsules daily. After the five-day treatment, the 2nd fecal sample will be collected. Both groups will receive a 23-day course of oral probiotics (two capsules twice daily) subsequently. The patients were asked to keep a diary to record bowel habits and register any adverse events. The 3rd fecal sample will be collected 28 days after the colonoscopy. The questionnaires will be completed 28 days and 84 days after the colonoscopy to assess responses of treatment. Polyethylene glycol and loperamide were allowed during the intervention as the rescue medication.

Biological: Colonscopic probiotics spray

Interventions

Colonscopic probiotics spray BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS).

You may not qualify if:

• Presence of immune deficiency or treatment with immune-modulating medication.
• Pregnant or lactating.
• Severe psychiatric disorder, or alcohol or drug abuse.
• Use of probiotics or treatment with antibiotics within 4 weeks prior to study entry.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

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MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Hsueh-Chien Chiang, M.D.

CONTACT

2353535; scion456scion@gmail.com

Po-Jun Chen, M.D.

CONTACT

2353535; pojunc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo powder was applied in the control group, and the powder was prepared in probiotics factory, which was blind to both patients and caregivers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 18, 2023
• Study Start: October 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 10 years