Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

Tongji University

Status: Enrolling

Conditions: Intractable Constipation; Pib Specific Phage

Treatments: Biological: phage

Study type: Interventional

Funder types: Other

Identifiers

NCT05973721

PIB-phage

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Phage treatment group

Experimental group

Treatment:

Biological: phage