Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease
CPIFGD
Value of Colonoscopic Probiotics Infusion in Patients With Functional Gastrointestinal Disease: a Prospective Randomized Controlled Study
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedStudy Start
First participant enrolled
July 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedAugust 4, 2022
April 1, 2022
4 months
April 24, 2022
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of adverse events related to treatment
8-12 weeks after start of treatment.
Other Outcomes (2)
Fecal microbiota
8-12 weeks after start of treatment.
Intestinal microbiota metabolites
8-12 weeks after start of treatment.
Study Arms (2)
Live Combined Bifidobacterium and Lactobacillus
EXPERIMENTALThe experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
Control
PLACEBO COMPARATORThe control group receive basic treatment and a single injection of normal saline through colonoscopy.
Interventions
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.
The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.
The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yun Feng, M.D.
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2022
First Posted
May 9, 2022
Study Start
July 4, 2022
Primary Completion
October 31, 2022
Study Completion
January 1, 2023
Last Updated
August 4, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share