Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

NCT ID: NCT05973721

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pib Specific Phage Intractable Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phage treatment group

Group Type EXPERIMENTAL

phage

Intervention Type BIOLOGICAL

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

Interventions

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phage

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huanlong Qin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongliang Tian, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Shanghai Tenth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongliang Tian, Dr

Role: CONTACT

+86-18917688267

Facility Contacts

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Hongliang Tian, Dr

Role: primary

+86-18917688267

Other Identifiers

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PIB-phage

Identifier Type: -

Identifier Source: org_study_id

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