Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

NCT05973721 | Unknown

• 1 other identifier: PIB-phage
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pib Specific Phage; Intractable Constipation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Phage treatment group

EXPERIMENTAL

Biological: phage

Interventions

phage BIOLOGICAL

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

Phage treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or lactating women.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, China

RECRUITING

Study Officials

• Hongliang Tian, Dr

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongliang Tian, Dr

CONTACT

+86-18917688267; tianhl@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 3, 2023
• Study Start: July 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Locations

CN (1)