Radiation EnteritisPhase 1/2NCT07331688
CMTS0515-auWMT for Radiation Enteritis
A Phase 1/2 study testing CMTS0515-augmented washed microbiota transplantation and Washed Microbiota Transplantation in people with Radiation Enteritis, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
This is a randomized controlled trial to explore the exploring the non-inferiority of CMTS0515-augmented WMT compared to WMT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Enteritis
- What is being tested?
- CMTS0515-augmented washed microbiota transplantation and Washed Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed diagnosis of abdominal or pelvic cancer;
- Completion of at least one entire course of radiation therapy;
- Age ≥18 years at the time of cancer diagnosis.
Who cannot join
- Absence of intestinal symptoms or transient intestinal symptoms;
- Radiation treatment involving areas outside the abdomen and pelvis;
- Diagnosis of antibiotic-associated diarrhea or use of antibiotics within four weeks before enrollment;
- Presence of intestinal comorbidities, including inflammatory bowel disease or pseudomembranous colitis;
- Presence of severe conditions rendering the patient unsuitable for inclusion;
- Experience of bowel surgery for RE-associated fistula.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
About this study
Official title: CMTS0515 - Augmented Washed Microbiota Transplantation Versus Washed Microbiota Transplantation in Radiation Enteritis: A Randomized, Double-Blind, Non-inferiority Trial
This is a randomized controlled trial to explore the exploring the non-inferiority of CMTS0515-augmented WMT compared to WMT.
Read the detailed description
At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the experimental group (CMTS0515-augmented WMT) and the control group (WMT). Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
- Conditions
- Radiation Enteritis
- Being tested
- CMTS0515-augmented washed microbiota transplantation, Washed Microbiota Transplantation
- Keywords
- Fecal Microbiota Transplantation, Washed Microbiota Transplantation, Radiotherapy, Radiation Enteritis, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMTS0515-augmented washed microbiota transplantationOther
Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube.
Washed Microbiota TransplantationOther
Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube.
| Study group | Role | What they receive |
|---|---|---|
| CMTS0515-augmented washed microbiota transplantation | Experimental | Patients undergo CMTS0515-augmented washed microbiota transplantation once a day for three consecutive days. Receives: Other: CMTS0515-augmented washed microbiota transplantation |
| washed microbiota transplantation | Active comparator | Patients undergo washed microbiota transplantation once a day for three consecutive days. Receives: Other: Washed Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical response rate after treatment
Radiation Therapy Oncology Group (RTOG) scores
Measured: 1 week, 4 weeks and 8 weeks
Secondary outcomes (2)
Scores of gastrointestinal symptoms
Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0
Measured: 1 week, 4 weeks and 8 weeks
Stool frequency and consistency
Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS)
Measured: 1 week, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start8 Dec 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EnteritisStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331688
- Sponsor's protocol ID
- WMT-CMTS0515-RE
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMTS0515 - Augmented Washed Microbiota Transplantation Versus Washed Microbiota Transplantation in Radiation Enteritis: A Randomized, Double-Blind, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07331688
- Acronym / sponsor ID
- WMT-CMTS0515-RE
- Conditions
- Radiation Enteritis
- Keywords
- Fecal Microbiota Transplantation, Washed Microbiota Transplantation, Radiotherapy, Radiation Enteritis, Randomized Controlled Trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to explore the exploring the non-inferiority of CMTS0515-augmented WMT compared to WMT.
Detailed description
At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the experimental group (CMTS0515-augmented WMT) and the control group (WMT). Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMTS0515-augmented washed microbiota transplantation | Experimental | Other: CMTS0515-augmented washed microbiota transplantationPatients undergo CMTS0515-augmented washed microbiota transplantation once a day for three consecutive days. |
| washed microbiota transplantation | Active comparator | Other: Washed Microbiota TransplantationPatients undergo washed microbiota transplantation once a day for three consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histopathologically confirmed diagnosis of abdominal or pelvic cancer;
- Completion of at least one entire course of radiation therapy;
- Age ≥18 years at the time of cancer diagnosis.
Key exclusion criteria (6 listed)
- Absence of intestinal symptoms or transient intestinal symptoms;
- Radiation treatment involving areas outside the abdomen and pelvis;
- Diagnosis of antibiotic-associated diarrhea or use of antibiotics within four weeks before enrollment;
- Presence of intestinal comorbidities, including inflammatory bowel disease or pseudomembranous colitis;
- Presence of severe conditions rendering the patient unsuitable for inclusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMTS0515-augmented washed microbiota transplantationLyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube. | Other | CMTS0515-augmented washed microbiota transplantation |
| Washed Microbiota TransplantationWashed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube. | Other | washed microbiota transplantation |
Primary outcome
The clinical response rate after treatment
Time frame: 1 week, 4 weeks and 8 weeks
Radiation Therapy Oncology Group (RTOG) scores
2 secondary outcomes
Scores of gastrointestinal symptoms
Time frame: 1 week, 4 weeks and 8 weeks
Stool frequency and consistency
Time frame: 1 week, 4 weeks and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CMTS0515-augmented washed microbiota transplantation and Washed Microbiota Transplantation in people with Radiation Enteritis, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical response rate after treatment (time frame: 1 week, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.