Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

Phase 4

• Conditions: Colonoscopy; Probiotics; Functional Constipation; Irritable Bowel Syndrome
• Interventions: Drug: Live Combined Bifidobacterium and Lactobacillus; Drug: Normal saline; Drug: Basic treatment

• Registration Number: NCT05366335
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. The invesitigators will randomize the included study subjects. The experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. The control group receive basic treatment and a single injection of normal saline through colonoscopy. The invesitigators will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. Other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-07-04
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Primary Completion: 2022-10-31
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients undergoing for colonoscopy
• Meet Rome IV diagnostic criteria for functional constipation or irritable bowel syndrome
• Voluntarily participate in this clinical study and sign the informed consent.

Exclusion Criteria

• Use of probiotics or antibiotics within the past 4 weeks
• History of intestinal surgery
• History of severe liver and kidney disease
• History of cardiovascular and cerebrovascular diseases
• History of neuropsychiatric diseases
• Pregnant women or lactating women
• Allergic to any ingredients of the live bacteria tablet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Live Combined Bifidobacterium and Lactobacillus	Live Combined Bifidobacterium and Lactobacillus	The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
Live Combined Bifidobacterium and Lactobacillus	Basic treatment	The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
Control	Normal saline	The control group receive basic treatment and a single injection of normal saline through colonoscopy.
Control	Basic treatment	The control group receive basic treatment and a single injection of normal saline through colonoscopy.

Primary Outcome Measures

Name	Time	Method
Proportion of effective patients with functional constipation and irritable bowel syndrome patients	8-12 weeks after start of treatment.	The efficacy of irritable bowel syndrome is evaluated by stool texture and abdominal discomfort related scales including IBS-SSS, BSS score, IBS-QOL,HADS and number of bowel movements per day in 12 weeks after start of treatment. The efficacy of functional constipation is evaluated by weekly defecation frequency, spontaneous complete bowel movement, and scales such as Wexner constipation score, BSS score, and PAC-QOL in 8 weeks after start of treatment.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events related to treatment	8-12 weeks after start of treatment.	The safety of single colonoscopic probiotics infusion was evaluated by incidence of adverse events related to colonoscopic probiotics infusion during the treatment and 8-12 weeks after the treatment.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China