Clinical trial NCT05366335: Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease
Official title: Value of Colonoscopic Probiotics Infusion in Patients With Functional Gastrointestinal Disease: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Functional Constipation
Irritable Bowel Syndrome
Probiotics
Colonoscopy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of effective patients with functional constipation and irritable bowel syndrome patients
timeFrame: 8-12 weeks after start of treatment.
Secondary outcomes:
measure: Incidence of adverse events related to treatment
timeFrame: 8-12 weeks after start of treatment.
Other outcomes:
measure: Fecal microbiota
timeFrame: 8-12 weeks after start of treatment.
measure: Intestinal microbiota metabolites
timeFrame: 8-12 weeks after start of treatment.
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yun Feng, M.D.
role: STUDY_CHAIR
References: