PouchitisEarly Phase 1NCT07878026
Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
A Early Phase 1 study testing MTB-targeted phage therapy in people with Pouchitis and UC - Ulcerative Colitis, run by Jinling Hospital, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pouchitis, UC - Ulcerative Colitis
- What is being tested?
- MTB-targeted phage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Oct 2029
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with pre-operative diagnosis of familial polyposis, Crohn's disease, or indeterminate colitis;
- Subjects who underwent temporary or permanent ileostomy without pouch construction;
- 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;
- Pregnant or lactating women;
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- Recent use of probiotic therapy;
- Patients who have received antibiotics within the past three months;
- Subjects deemed unsuitable for participation in this study at the investigator's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Yinan Yan, M.D., +8617312883979, yanyinan0000@163.com
About this study
Official title: 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:
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- 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.
- Conditions
- Pouchitis, UC - Ulcerative Colitis
- Being tested
- MTB-targeted phage therapy
- Medical subject headings
- Pouchitis, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTB-targeted phage therapyBiological
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 group | Role | What they receive |
|---|---|---|
| Pouchitis | Experimental | Adult patients aged 18-70 years with pouchitis after IPAA surgery for ulcerative colitis, who test positive for MTB bacteria or aerolysin**. Receives: Biological: MTB-targeted phage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a decrease in Modified Pouchitis Disease Activity Index (mPDAI) total score from 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.
Measured: Baseline to Week 14
Secondary outcomes (10)
Percentage of Participants in Clinical Remission at Week 14 Based on the Modified Pouchitis Disease Activity Index (mPDAI)
Clinical remission of pouchitis will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). Clinical remission is defined as an mPDAI score ≤4 points and a decrease of ≥2 points from baseline. The percentage of participants who meet the criteria for clinical remission at Week 14 will be evaluated.
Measured: Week 14
Percentage of Participants in Clinical Remission at Week 34 Based on the Modified Pouchitis Disease Activity Index (mPDAI)
Clinical remission of pouchitis will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). Clinical remission is defined as an mPDAI score ≤4 points and a decrease of ≥2 points from baseline. The outcome will be reported as the percentage (%) of participants who meet both criteria for clinical remission at Week 34.
Measured: Week 34
Percentage of Participants With Sustained Clinical Remission at Week 34 Based on the Modified Pouchitis Disease Activity Index (mPDAI)
Sustained clinical remission will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). Sustained clinical remission is defined as clinical remission at both Week 14 and Week 34. Clinical remission is defined as an mPDAI score ≤4 points and a decrease of ≥2 points from baseline. The percentage of participants who meet the criteria for sustained clinical remission at Week 34 will be evaluated.
Measured: Week 14 through Week 34
Percentage of Participants in Endoscopic Remission at Week 14 Based on the Modified Pouchitis Disease Activity Index Endoscopic Subscore (mPDAI-E)
Endoscopic remission will be assessed by endoscopic evaluation of the pouch. Endoscopic remission is defined as normalization of the mucosal appearance, clear vascular pattern, and absence of exudate or secretions.mPDAI-E≤1. The outcome will be reported as the percentage (%) of participants who meet the criteria for endoscopic remission at Week 14.
Measured: Week 14
Percentage of Participants in Endoscopic Remission at Week 34 Based on the Modified Pouchitis Disease Activity Index Endoscopic Subscore (mPDAI-E)
Endoscopic remission will be assessed by endoscopic evaluation of the pouch. Endoscopic remission is defined as normalization of the mucosal appearance, clear vascular pattern, and absence of exudate or secretions.mPDAI-E≤1. The outcome will be reported as the percentage (%) of participants who meet the criteria for endoscopic remission at Week 34.
Measured: Week 34
Active MTB Phage Concentration in Fresh Stool Samples (PFU/g)
Active MTB phage concentration will be measured in fresh stool samples using a plaque assay. Approximately 1-2 g of fresh stool will be collected at each assessment. Active MTB phage concentration will be reported as plaque-forming units per gram of stool (PFU/g). Samples will be collected 24-48 hours after the first oral administration of MTB phage and at Weeks 2, 8, 14, 24, and 34.
Measured: 24-48 hours after the first dose and Weeks 2, 8, 14, 24, and 34
Fecal MTB Bacterial Abundance Measured by Culture (CFU/g)
Fecal MTB bacterial abundance will be assessed by culture using an Aeromonas-selective culture medium. Fresh stool samples of approximately 1-2 g will be collected at Weeks 2, 8, 14, 24, and 34. MTB bacterial abundance will be reported as colony-forming units per gram of stool (CFU/g).
Measured: Weeks 2, 8, 14, 24, and 34
Fecal MTB Bacterial Load Measured by Quantitative Polymerase Chain Reaction (qPCR) (CFU/mg)
Fecal MTB bacterial load will be quantified using quantitative polymerase chain reaction (qPCR). Fresh stool samples of approximately 1-2 g will be collected at Weeks 2, 8, 14, 24, and 34. The qPCR cycle threshold (Ct) values will be converted to MTB bacterial load and reported as colony-forming units per milligram of stool (CFU/mg).
Measured: Weeks 2, 8, 14, 24, and 34
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 34 (Points)
Patient-reported quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The change in IBDQ total score from baseline to Week 34 will be calculated by subtracting the baseline total score from the Week 34 total score. Scores will be reported in points.
Measured: Baseline to Week 34
Incidence of Adverse Events Through Week 14 (%)
Adverse events will be coded using the Chinese version of the Medical Dictionary for Regulatory Activities (MedDRA). Adverse events will be summarized by study period (screening period and treatment period), System Organ Class (SOC), and Preferred Term (PT). The numbers of participants and events and the incidence of adverse events will be summarized. Treatment-related adverse events, serious adverse events, adverse events leading to study discontinuation, and important adverse events will also be summarized. Adverse events will be summarized by severity (mild, moderate, or severe).
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing University
- Responsible party
- Principal investigator, Fangyu Wang, Jinling Hospital, China
- Investigators
- Fangyu Wang, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878026
- Sponsor's protocol ID
- JinlingH-2026DZKY-103-01
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No