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A preliminary study on the treatment of radiation enteritis by fecal bacteria transplantation

A preliminary study on the treatment of radiation enteritis by fecal bacteria transplantation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062627
Enrollment
Unknown
Registered
2022-08-14
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radiation enteritis

Interventions

Acute radiation enteritis:Fecal bacteria transplantation
Chronic radiation enteritis: Fecal bacteria transplantation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. It conforms to the consensus of experts on diagnosis and treatment of radioactive proctitis in China (2018 edition); 2. Aged 18-75 years, regardless of gender; 3. Severity classification based on colonoscopy (Vienna proctoscopy score) >=2 or clinical classification based on post-radiotherapy response scale (RTOG/EORTC) >=2; 4. Voluntarily participate in the experiment and sign the informed consent, and can cooperate with sampling and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with intestinal perforation, intestinal obstruction, sepsis and other diseases; mental abnormality; severe immune deficiency; fever; 2. Those who have used antibiotics, proton pump inhibitors, probiotics, prebiotics and other drugs and preparations affecting intestinal microorganisms in the past 1 month; 3. The vaccine was administered or expected to be administered within the last 3 months, during the study period, or within 6 months after the last study administration; 4. Pregnant or lactating (lactating) women; 5. Severe comorbidity; 6. Abnormal laboratory results: serum creatinine level more than 2.0 mg/dL (176.8µmol/L); Total white blood cell (WBC) count at screening < 2500 /µL, or blood plates < 100000/µL or neutrophils < 1500/µL; 7. They are participating in clinical trials or have completed other clinical trials for less than 3 months; 8. Due to other circumstances, the investigator considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Vienna Colonoscopy Score or Response to Radiotherapy Scale (RTOG/EORTC);

Countries

China

Contacts

Public ContactPeng Lihua

Chinese PLA General Hospital

penglihua301@126.com+86 13621279531

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026