Status:
RECRUITING
Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract
Lead Sponsor:
The Second Hospital of Nanjing Medical University
Collaborating Sponsors:
The First Affiliated Hospital of Guangdong Pharmaceutical University
Nanjing Medical University
Conditions:
Malnutrition
Gastroenterostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized, multicenter study to evaluate WMT in improving nutritional status in malnourished patients who underwent nonphysiological reconstruction of the upper gastrointestina...
Detailed Description
Background: Malnutrition is a common complication of nonphysiological reconstruction of the upper gastrointestinal tract. The potential of washed microbiota transplantation (WMT) in improving nutritio...
Eligibility Criteria
Inclusion
- Patients undergone nonphysiological reconstruction of the gastrointestinal tract (such as Billroth-II, Roux-en-Y, Child, Whipple reconstruction)
- Aged over 18 years old;
- Malnutrition is assessed by Nutritional Risk Screening 2002 score≥3 and Patient Generated Subjective Global Assessment (PG-SGA) score≥4;
- Written informed consent;
Exclusion
- Expected survival time \< 3 months;
- Still on anti-tumor therapy or it is expected during the visit;
- Complicated with ascites or edema caused by malnutrition;
- Known organic gastrointestinal disease (e.g., gastrointestinal infection, inflammatory bowel disease, or radiation enteritis);
- Undergone other gastrointestinal surgery (e.g., enterectomy, enterostomy, or gastrostomy) except appendectomy or anal fistula surgery;
- Complicated with contraindications of enteral nutrition such as ileus, active gastrointestinal bleeding, and shock;
- Cannot tolerate gastroscopy or colonoscopy;
- Severe comorbidities (e.g., diabetes, cardiopulmonary failure, severe liver or or kidney diseases);
- Complicated with other wasting diseases (e.g., active tuberculosis, hyperthyroidism, diabetes, HIV, active hepatitis, hip fracture, craniocerebral injury, etc.);
- A history of anti-infective treatment within 30 days before enrollment; or need anti-infective treatment at the time of enrollment; or unwilling to stop taking drugs that affect gut microbes, such as probiotics;
- Can not tolerate oral enteral nutrition;
- Women who are pregnant or breastfeeding;
- Participating in another clinical trial;
- Deemed unsuitable for inclusion by the investigators.
Key Trial Info
Start Date :
October 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05439135
Start Date
October 20 2024
End Date
October 31 2025
Last Update
July 10 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000