Back to results

Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

Primary Purpose

Pib Specific Phage, Intractable Constipation

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

phage

About this trial

This is an interventional treatment trial for Pib Specific Phage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients of both sexes, aged 18-70 years, with confirmed chronic constipation and positive fecal bacteria test for PIB, agreed to participate in this experiment and signed an informed consent. Exclusion Criteria: Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or lactating women.

Sites / Locations

Shanghai Tenth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phage treatment group

Arm Description

Outcomes

Primary Outcome Measures

To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.

Defecation behavior: A questionnaire was designed according to Rome IV criteria, and the questionnaire was collected and recorded, including the number of spontaneous bowel movements per week, PAC-QoL score, PAC-SYM score and Bristol stool trait score

The concentration of phage in feces was detected to evaluate the survival and survival ratio of active phage in the intestinal tract of patients.

Real-time PCR was used to detect the nucleic acid of PIB bacteria and HPLC was used to detect the distribution of fecal PIB phage in the intestinal tract of patients with refractory constipation

Secondary Outcome Measures

Full Information

NCT ID

NCT05973721

First Posted

July 17, 2023

Last Updated

July 25, 2023

Sponsor

Shanghai 10th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05973721

Brief Title

Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

Official Title

To Investigate the Clinical Efficacy and Safety of Phage Therapy for Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The overall aim was to evaluate the efficacy of PiB-specific phages for the treatment of refractory constipation through clinical studies, primarily for the publication of scientific papers and to guide the development of phage therapies. The purpose of this study will be subdivided into three aspects from three aspects: target exposure level, target occupation, and functional effects after acting on the target, including:1) The distribution of PIB phage in the intestine of patients with refractory constipation;2) The killing effect of PIB phage on PIB bacteria in refractory constipation patients;And 3) therapeutic effect of PIB phage on patients with refractory constipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pib Specific Phage, Intractable Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phage treatment group

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

phage

Intervention Description

The treatment group was given one phage each time, once a day for two weeks

Primary Outcome Measure Information:

Title

To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.

Description

Time Frame

Baseline and six months after treatment

Title

The concentration of phage in feces was detected to evaluate the survival and survival ratio of active phage in the intestinal tract of patients.

Time Frame

Baseline and 24-48 hours after phage administration (first bowel movement)

Title

Real-time PCR was used to detect the nucleic acid of PIB bacteria and HPLC was used to detect the distribution of fecal PIB phage in the intestinal tract of patients with refractory constipation

Time Frame

Baseline and two weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongliang Tian, Dr

Phone

+86-18917688267

tianhl@tongji.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongliang Tian, Dr

Organizational Affiliation

Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Tenth People's Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongliang Tian, Dr

Phone

+86-18917688267

tianhl@tongji.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

We'll reach out to this number within 24 hrs