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NCT07878026
This is a Single-center, Prospective, Single-arm Clinical Study Designed to Evaluate the Efficacy and Safety of Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC).
Conditions: Pouchitis, UC - Ulcerative Colitis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 12
Sponsor: Jinling Hospital, China
Location: Affiliated Jinling Hospital, Medical School of Nanjing University Nanjing Jiangsu
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Male and female subjects aged 18-70 years;
2. Confirmed diagnosis of ulcerative colitis (UC) prior to IPAA, with pouch takedown completed for at least 3 months;
3. Patients with pouchitis and an mPDAI score ≥ 5 points;
4. Positive stool test for MTB bacteria or Aeromonas aerolysin;
5. Subjects who agree to participate in this clinical study and have provided written informed consent.
Exclusion Criteria:
1. Patients with pre-operative diagnosis of familial polyposis, Crohn's disease, or indeterminate colitis;
2. Subjects who underwent temporary or permanent ileostomy without pouch construction;
3. Active cardiovascular and cerebrovascular diseases including coronary heart disease, hypertension, cerebral infarction;
4. Patients suffering from other systemic diseases, autoimmune diseases, malignant tumors, or other severe chronic illnesses;
5. History of psychotropic substance abuse;
6. Pregnant or lactating women;
7. Recent use of probiotic therapy;
8. Patients who have received antibiotics within the past three months;
9. Subjects deemed unsuitable for participation in this study at the investigator's discretion.
Source: ClinicalTrials.gov (NCT07878026). StuddyBuddy aggregates publicly available trial information.