Using phage therapy to treat chronic constipation
To Investigate the Clinical Efficacy and Safety of Phage Therapy for Chronic Constipation
This study is testing whether a new treatment using special viruses can help people with chronic constipation feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05973721 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the efficacy and safety of PiB-specific phages in treating patients with refractory constipation. The research will focus on three main aspects: the distribution of PIB phages in the intestines, their ability to kill PIB bacteria, and the overall therapeutic effects on patients suffering from chronic constipation. Participants will be monitored for their response to the phage treatment, with the goal of generating data to support the development of phage therapies for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with confirmed chronic constipation and a positive fecal bacteria test for PIB.
Not a fit: Patients with severe heart failure, hypertension, cerebrovascular diseases, or secondary constipation due to psychotropic drug abuse will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients suffering from chronic constipation.
How similar studies have performed: While phage therapy is a novel approach, there have been limited studies exploring its efficacy in treating gastrointestinal conditions, making this study a potentially groundbreaking effort.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Shanghai Tenth People's Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Hongliang Tian, Dr — Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
- Study coordinator: Hongliang Tian, Dr
- Email: tianhl@tongji.edu.cn
- Phone: +86-18917688267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.