Oral bacteriophage treatment for pouchitis after surgery for ulcerative colitis
Tests a bacteriophage taken by mouth in adults with pouchitis after colitis surgery.
Plain-language title generated from the registry record
Registry title: Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-70 who have pouchitis after pouch surgery for ulcerative colitis and have MTB bacteria or aerolysin in their stool.
- Age
- 18 to 70 years
- Sex
- Men and women can join.
- Disease stage
- Pouchitis with an mPDAI score of 5 points or more. Ulcerative colitis was confirmed before the pouch (IPAA) surgery, and the pouch takedown was completed at least 3 months ago.
- Earlier treatment
- No antibiotics in the past three months. No recent probiotic therapy.
- Biomarker or test result
- Stool test positive for MTB bacteria or Aeromonas aerolysin.
Main reasons for not taking part
- Before surgery, a diagnosis of familial polyposis, Crohn's disease, or indeterminate colitis
- Temporary or permanent ileostomy without a pouch
- Active heart or brain blood vessel disease, such as coronary heart disease, hypertension, or cerebral infarction
- Other systemic diseases, autoimmune diseases, malignant tumors, or other severe chronic illnesses
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07878026, who can take part
Where in China
- Affiliated Jinling Hospital, Medical School of Nanjing UniversityNanjing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jinling Hospital, China
- Trial code
- NCT07878026
- Record updated
- 22 October 2026
- Original description
The goal of this single-arm, prospective clinical trial is to assess the clinical efficacy and safety of oral Aeromonas sp. MTB-specific phage therapy in adult participants aged 18-70 years with pouchitis following ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, who are positive for stool MTB bacteria or aerolysin.Read full original descriptionShow less
A Single-center, Prospective, Single-arm Clinical Research Protocol for the Treatment of Pouchitis With Aeromonas sp. MTB Bacteriophage
The goal of this single-arm, prospective clinical trial is to assess the clinical efficacy and safety of oral Aeromonas sp. MTB-specific phage therapy in adult participants aged 18-70 years with pouchitis following ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, who are positive for stool MTB bacteria or aerolysin.
The main questions it aims to answer are:
* Does 2-week oral MTB phage treatment lead to mPDAI-defined pouchitis remission at Week 14? * What is the safety profile of oral MTB phage intervention in this patient population? No external control group is utilised; baseline data of each participant serves as self-control.
Participants will:
* Receive once-daily oral MTB phage (one bottle, 30 minutes post-meal) for 14 consecutive days. * Complete mPDAI symptom questionnaires and IBDQ quality-of-life assessments at baseline and follow-up time-points (Weeks 2, 8, 14, 24, 34). * Provide stool specimens for measurement of faecal phage titre, MTB bacterial load and aerolysin level at 24-48 hours post-initial phage administration, Weeks 2, 8, 14, 24 and 34. * Undergo pouch endoscopy for mPDAI endoscopic scoring at baseline, Week 14 and Week 34. * Complete scheduled follow-up up to Week 34, with continuous monitoring of vital signs, laboratory parameters and all adverse events throughout the study period.
Inclusion: Male and female subjects aged 18-70 years; Confirmed diagnosis of ulcerative colitis (UC) prior to IPAA, with pouch takedown completed for at least 3 months; Patients with pouchitis and an mPDAI score ≥ 5 points; Positive stool test for MTB bacteria or Aeromonas aerolysin; Subjects who agree to participate in this clinical study and have provided written informed consent.
Exclusion: Recent use of probiotic therapy; Patients who have received antibiotics within the past three months; Patients with pre-operative diagnosis of familial polyposis, Crohn's disease, or indeterminate colitis; Active cardiovascular and cerebrovascular diseases including coronary heart disease, hypertension, cerebral infarction; Patients suffering from other systemic diseases, autoimmune diseases, malignant tumors, or other severe chronic illnesses; History of psychotropic substance abuse; Subjects who underwent temporary or permanent ileostomy without pouch construction; Pregnant or lactating women; Subjects deemed unsuitable for participation in this study at the investigator's discretion.