Colonoscopic Probiotics Infusion for Functional Gastrointestinal Disease (CPIFGD)

August 2, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Live Combined Bifidobacterium and Lactobacillus
The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy.
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.
Other Names:
  • Live combined Bifidobacterium and Lactobacillus solution infusion through colonoscopy
Drug: Basic treatment
The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.
Placebo Comparator: Control
The control group receive basic treatment and a single injection of normal saline through colonoscopy.
Drug: Basic treatment
The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment.
Drug: Normal saline
The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group.
Other Names:
  • Normal saline as placebo infusion through colonoscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of effective patients with functional constipation and irritable bowel syndrome patients
Time Frame: 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.
8-12 weeks after start of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events related to treatment
Time Frame: 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.
8-12 weeks after start of treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal microbiota
Time Frame: 8-12 weeks after start of treatment.
16S rRNA detection of fecal intestinal flora.
8-12 weeks after start of treatment.
Intestinal microbiota metabolites
Time Frame: 8-12 weeks after start of treatment.
Detection of gut microbiota metabolites in blood and feces by HPLC-MS/MS.
8-12 weeks after start of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yun Feng, M.D., First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2022LSK-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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