Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

Study Overview
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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.

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

Conditions
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Pib Specific Phage, Intractable Constipation

Intervention / Treatment
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* Biological: phage


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phage treatment group<br> | Biological: phage<br>* The treatment group was given one phage each time, once a day for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and six months after treatment | 
| The concentration of phage in feces was detected to evaluate the survival and survival ratio of active phage in the intestinal tract of patients. |  | Baseline and 24-48 hours after phage administration (first bowel movement) | 
| 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 |  | Baseline and two weeks after treatment |