Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Functional Constipation Irritable Bowel Syndrome Probiotics Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Live Combined Bifidobacterium and Lactobacillus

The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.

Group Type EXPERIMENTAL

Live Combined Bifidobacterium and Lactobacillus

Intervention Type DRUG

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.

Basic treatment

Intervention Type DRUG

The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.

Control

The control group receive basic treatment and a single injection of normal saline through colonoscopy.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.

Basic treatment

Intervention Type DRUG

The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Basic treatment

The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.

Intervention Type DRUG

Other Intervention Names

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Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopy Normal saline as placebo infusion through colonoscopy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No