Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease

NCT05366335 — Phase 4, Unknown, 160 participants, First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05366335, acronym CPIFGD
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	160 (Estimated)
Sponsor	First Affiliated Hospital Xi'an Jiaotong University (Other)
Conditions	Functional Constipation, Irritable Bowel Syndrome, Probiotics, Colonoscopy
Interventions	Live Combined Bifidobacterium and Lactobacillus, Normal saline, Basic treatment (Drug)
Dates	start 2022-07-04, primary completion 2022-10-31 (estimated), completion 2023-01-01 (estimated), first posted 2022-05-09, last updated 2022-08-04
Locations	1 site in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Live Combined Bifidobacterium and Lactobacillus	Experimental	Drug: Live Combined Bifidobacterium and Lactobacillus; Drug: Basic treatment	The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
Control	Placebo comparator	Drug: Normal saline; Drug: Basic treatment	The control group receive basic treatment and a single injection of normal saline through colonoscopy.

Live Combined Bifidobacterium and Lactobacillus (Drug), also known as Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopy: 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 (Drug), also known as Normal saline as placebo infusion through colonoscopy: The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.
Basic treatment (Drug): The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.

+Outcome measures

Primary outcomes

Proportion of effective patients with functional constipation and irritable bowel syndrome patients [8-12 weeks after start of treatment.]: 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.

Secondary outcomes

Incidence of adverse events related to treatment [8-12 weeks after start of 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.

Other outcomes

Fecal microbiota [8-12 weeks after start of treatment.]: 16S rRNA detection of fecal intestinal flora.
Intestinal microbiota metabolites [8-12 weeks after start of treatment.]: Detection of gut microbiota metabolites in blood and feces by HPLC-MS/MS.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
First Affiliated Hospital of Xi'an Jiaotong University	Xi'an, Shaanxi	China	Recruiting

+Investigators

Yun Feng, M.D., Study chair, First Affiliated Hospital Xi'an Jiaotong University

My Notes

Public

To Read Reading Read