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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05366335
Other study ID # XJTU1AF2022LSK-205
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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.
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