Radiation Enteritis
Conditions
Keywords
Fecal Microbiota Transplantation, Washed Microbiota Transplantation, Radiotherapy, Radiation Enteritis, Randomized Controlled Trial
Brief summary
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.
Interventions
OTHERCMTS0515-augmented washed microbiota transplantation
Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube.
Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histopathologically confirmed diagnosis of abdominal or pelvic cancer; 2. Completion of at least one entire course of radiation therapy; 3. Age ≥18 years at the time of cancer diagnosis.
Exclusion criteria
1. Absence of intestinal symptoms or transient intestinal symptoms; 2. Radiation treatment involving areas outside the abdomen and pelvis; 3. Diagnosis of antibiotic-associated diarrhea or use of antibiotics within four weeks before enrollment; 4. Presence of intestinal comorbidities, including inflammatory bowel disease or pseudomembranous colitis; 5. Presence of severe conditions rendering the patient unsuitable for inclusion; 6. Experience of bowel surgery for RE-associated fistula.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical response rate after treatment | 1 week, 4 weeks and 8 weeks | Radiation Therapy Oncology Group (RTOG) scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores of gastrointestinal symptoms | 1 week, 4 weeks and 8 weeks | Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0 |
| Stool frequency and consistency | 1 week, 4 weeks and 8 weeks | Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS) |
Countries
China
Outcome results
None listed