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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    160
  • sponsor
    First Affiliated Hospital Xi'an Jiaotong University
Updated on 19 August 2022
constipation
microbiota

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.

Details
Condition Functional Constipation, Irritable Bowel Syndrome, Probiotics, Colonoscopy
Treatment Normal saline, basic treatment, Live Combined Bifidobacterium and Lactobacillus
Clinical Study IdentifierNCT05366335
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last Modified on19 August 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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