Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

Study Overview
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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.

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

Conditions
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Functional Constipation, Irritable Bowel Syndrome, Probiotics, Colonoscopy

Intervention / Treatment
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* Drug: Live Combined Bifidobacterium and Lactobacillus
* Drug: Normal saline
* Drug: Basic treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live Combined Bifidobacterium and Lactobacillus<br>The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy. | Drug: Live Combined Bifidobacterium and Lactobacillus<br>* 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.<br>* Other names: Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopy;Drug: Basic treatment<br>* The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.<br>|
| Placebo Comparator: Control<br>The control group receive basic treatment and a single injection of normal saline through colonoscopy. | Drug: Normal saline<br>* The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.<br>* Other names: Normal saline as placebo infusion through colonoscopy;Drug: Basic treatment<br>* The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of effective patients with functional constipation and irritable bowel syndrome patients | 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. | 8-12 weeks after start of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events related to 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. | 8-12 weeks after start of treatment. |