Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phage treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phage | Biological | The treatment group was given one phage each time, once a day for two weeks |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongliang Tian, Dr | Contact | +86-18917688267 | tianhl@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongliang Tian, Dr | Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided