Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease (CPIFGD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; Probiotics; Colonoscopy; Functional Constipation
• Intervention / Treatment: Drug: Live Combined Bifidobacterium and Lactobacillus; Drug: Basic treatment; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hongxia Li, M.D.; Phone Number: 0086-029-85323920; Email: hongxia1105@126.com
• Study Contact Backup: Name: Yun Feng, M.D.; Phone Number: 0086-029-85323920; Email: amyyun@xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Yun Feng; Phone Number: 0086-029-85323920; Email: amyyun@xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live Combined Bifidobacterium and Lactobacillus; 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; 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.; Other Names: Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopy; Drug: Basic treatment; The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.
Placebo Comparator: Control; The control group receive basic treatment and a single injection of normal saline through colonoscopy.	Drug: Basic treatment; The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.; 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.; Other Names: Normal saline as placebo infusion through colonoscopy

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microbiota	16S rRNA detection of fecal intestinal flora.	8-12 weeks after start of treatment.
Intestinal microbiota metabolites	Detection of gut microbiota metabolites in blood and feces by HPLC-MS/MS.	8-12 weeks after start of treatment.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Yun Feng, M.D., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Constipation
• Other Study ID Numbers: XJTU1AF2022LSK-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No