Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

Irritable Bowel Syndrome Clinical Trial

— CPIFGD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366335
• Other study ID #: XJTU1AF2022LSK-205
• Status: Recruiting
• Phase: Phase 4
• Start date: July 4, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yun Feng, M.D.
• Phone: 0086-029-85323920
• Email: amyyun[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 1, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Constipation
• Digestive System Diseases
• Functional Constipation
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Probiotics

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

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