Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

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

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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Yun Feng, M.D. · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-04

Primary Completion

2022-10-31

Completion

2023-01-01

Countries

• China

Study Locations