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New treatment option for Radiation Induced Proctitis
Official title Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
ClinicalTrials.gov ID: NCT06776029
What this study is testing
What is Fecal Microbiota Transplantation Capsule?
Fecal Microbiota Transplantation Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for radiation induced proctitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are: Dose FMT alleviate the symptom of severe rectal bleeding?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18-75 years old
- At least 3 months since the completion of pelvic radiotherapy
- No evidence of tumor recurrence or metastasis
- Rectal bleeding with grade 2-4 by LENT-SOMA scales
- Colonoscopy indicating rectal congested mucosa or telangiectasia
You likely can't join if
- Acute or chronic infectious diseases
- Serious systemic diseases
- Known allergies to any components of the study medication
- Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
- Late complications related to pelvic radiation injury
- Other hemorrhagic or coagulation disorders
See the full eligibility criteria
- Age: 18-75 years old
- At least 3 months since the completion of pelvic radiotherapy
- No evidence of tumor recurrence or metastasis
- Rectal bleeding with grade 2-4 by LENT-SOMA scales
- Colonoscopy indicating rectal congested mucosa or telangiectasia
- Poor response to supportive care, or hemoglobin level less than or equal to 70 g/L in the past 3 months
- Acute or chronic infectious diseases
- Serious systemic diseases
- Known allergies to any components of the study medication
- Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
- Late complications related to pelvic radiation injury
- Other hemorrhagic or coagulation disorders
- Previous rectal resection
- Bowel obstruction or perforation that require surgery
- Cognitive or psychological disorder
- Contraindications to FMT administration
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.