NCT05366335

Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

Value of Colonoscopic Probiotics Infusion in Patients With Functional Gastrointestinal Disease: a Prospective Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Constipation
• Irritable Bowel Syndrome
• Probiotics
• Colonoscopy

Interventions

Type	Name	Description
DRUG	Live Combined Bifidobacterium and Lactobacillus	The invesitigators give patients Live Combined Bifidobacterium and Lactobacillus solution infusion during their colonoscopy examination for a single time in the Live Combined Bifidobacterium and Lactobacillus group.
DRUG	Normal saline	The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.
DRUG	Basic treatment	The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.

Timeline

• Start date: 2022-07-04
• Primary completion: 2022-10-31
• Completion: 2023-01-01
• First posted: 2022-05-09
• Last updated: 2022-08-04

Locations

1 site across 1 country: China