UCNot yet recruiting

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).

Early Phase 1 · Testing MTB-targeted phage therapy · 1 site · Jinling Hospital, China

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing MTB-targeted phage therapy (a biologic) as a possible treatment. Condition(s) listed: Pouchitis and UC - Ulcerative Colitis.

It is open-label: participants know what they are receiving.

Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.

Who can join

Ages 18 to 70
Any sex

Some of the main requirements, copied from the record:

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.

There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 12 participants are expected to take part.
The study has 1 group.
Start date: 2027-01-01 (planned).
Main results expected around 2028-12-31 (estimate from the record).
1 study site listed in China.

Groups in this study

Pouchitis (listed as: experimental group)

Main thing being measured

Percentage of participants with a decrease in Modified Pouchitis Disease Activity Index (mPDAI) total score from baseline to week 14 (Baseline to Week 14)

In the researchers’ words

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…

Words you might see

Endoscopy: a camera exam inside the digestive tract.
Remission: a period when the disease is quiet or under control.
Ileal pouch (IPAA): an internal pouch made from the small intestine after the colon is removed; pouchitis is inflammation of it.

General definitions, not specific to this trial.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Early Phase 1
Study type	Interventional
Conditions	Pouchitis; UC - Ulcerative Colitis
Lead sponsor	Jinling Hospital, China
Collaborators	Nanjing University
Enrollment	12 (estimated)
Start date	2027-01-01
Primary completion (est.)	2028-12-31
First posted	2026-10-16
Last updated	2026-10-16
Official title	A Single-center, Prospective, Single-arm Clinical Research Protocol for the Treatment of Pouchitis With Aeromonas sp. MTB Bacteriophage
ClinicalTrials.gov ID	NCT07878026

Interventions

MTB-targeted phage therapy (Biological)
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…

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
Affiliated Jinling Hospital, Medical School of Nanjing University	Nanjing, Jiangsu	China

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.