An interventional study of phage in Pib Specific Phage and Intractable Constipation, sponsored by Shanghai 10th People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Biological: phage
The treatment group was given one phage each time, once a day for two weeks
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
Time frame: 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.
Time frame: 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
Time frame: Baseline and two weeks after treatment
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Shanghai 10th People's Hospital