Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)

Condition(s) studied

Investigational drug(s) / intervention(s)

MTB-targeted phage therapy: Aeromonas nov. subsp. macrophage-toxic bacteria (MTB) is a newly-identified enteropathogen associated with ulcerative colitis (UC). It secretes aerolysin to specifically damage colonic macrophages. MTB phage is a bacteriophage targeting this pathogen, which can safely and efficiently eliminate MTB in animal models. Treatment regimen: One bottle per dose, once daily, taken half an hour after meals for two weeks. Patient symptoms shall be assessed after each treatment session.

Study 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

Primary outcome measure(s)

• Percentage of participants with a decrease in Modified Pouchitis Disease Activity Index (mPDAI) total score from baseline to week 14 — Baseline to Week 14
  The severity of pouchitis will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). The mPDAI was used to evaluate patients' clinical symptoms (including stool frequency, rectal bleeding, fecal urgency, abdominal cramps, and presence of fever) and endoscopic inflammation (edema, granularity, fragility, loss of the vascular pattern, mucous exudates, and ulceration) . The percentage of participants with a decrease in mPDAI total score from baseline to Week 14 will be evaluated. A decrease in mPDAI total score is defined as a Week 14 mPDAI total score lower than the baseline mPDAI total score.

Trial sites (1)

More Jinling Hospital, China trials in China

Other trials for the same condition