Pib Specific PhageNCT05973721
Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety
A study testing phage in people with Pib Specific Phage and Intractable Constipation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pib Specific Phage, Intractable Constipation
- What is being tested?
- phage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai
Hongliang Tian, Dr, +86-18917688267, tianhl@tongji.edu.cn
About this study
Official title: To Investigate the Clinical Efficacy and Safety of Phage Therapy for Chronic Constipation
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
- Being tested
- phage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phageBiological
The treatment group was given one phage each time, once a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Phage treatment group | Experimental | Not described Receives: Biological: phage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: Baseline and two weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pib Specific PhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
- Investigators
- Hongliang Tian, Dr, Principal investigator, Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973721
- Sponsor's protocol ID
- PIB-phage
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Clinical Efficacy and Safety of Phage Therapy for Chronic Constipation
- ClinicalTrials.gov ID
- NCT05973721
- Acronym / sponsor ID
- PIB-phage
- Conditions
- Pib Specific Phage, Intractable Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phage treatment group | Experimental | Biological: phage |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phageThe treatment group was given one phage each time, once a day for two weeks | Biological | Phage treatment group |
Primary outcome
To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients.
Time frame: Baseline and six months after treatment
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongliang Tian, Dr principal investigator
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phage in people with Pib Specific Phage and Intractable Constipation, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongliang Tian, Dr (+86-18917688267, tianhl@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the curative effect of PIB phage on refractory constipation by defecation behavior of patients. (time frame: Baseline and six months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.