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
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?
Trial 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.