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Clinical trial

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

ID
Name
PIB-phage
Description
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.
Trial arms
Trial start
2023-07-01
Estimated PCD
2023-09-01
Trial end
2023-10-01
Status
Recruiting
Treatment
phage
The treatment group was given one phage each time, once a day for two weeks
Arms:
Phage treatment group
Size
50
Primary endpoint
To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-08-03

1 organization

1 product

2 indications

Organization
Shanghai 10th People's Hospital
Product
phage
Indication
Phage IBP specific
Indication
Constipation