NCT07878026Not yet recruitingEarly phase 1
Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
A Single-center, Prospective, Single-arm Clinical Research Protocol for the Treatment of Pouchitis With Aeromonas sp. MTB Bacteriophage
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Jinling Hospital, China
- Diseases
- Ulcerative colitis
- NCT number
- NCT07878026
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 12
- From 1 Jan 2027 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of probiotic therapy;
- Patients who have received antibiotics within the past three months;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Jinling Hospital, Medical School of Nanjing University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.