Actively Recruiting
Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract
Led by The Second Hospital of Nanjing Medical University · Updated on 2025-07-10
62
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
Sponsors
T
The Second Hospital of Nanjing Medical University
Lead Sponsor
T
The First Affiliated Hospital of Guangdong Pharmaceutical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, randomized, multicenter study to evaluate WMT in improving nutritional status in malnourished patients who underwent nonphysiological reconstruction of the upper gastrointestinal tract. In this multicenter trial, sixty-two patients will be enrolled in forteen Chinese sites. Participants will be randomized at a ratio of 1:1 to receive three WMTs through either mid-gut tube or colonic TET. After WMT, each participant will receive free diet plus home enteral nutrition. Home enteral nutrition should last for 2 months at home, with blood, urine and stool samples taken and stored at baseline and 2 months after WMT.
CONDITIONS
Official Title
Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone nonphysiological reconstruction of the gastrointestinal tract such as Billroth-II, Roux-en-Y, Child, or Whipple reconstruction
- Age over 18 years old
- Malnutrition assessed by Nutritional Risk Screening 2002 score ≥3 and Patient Generated Subjective Global Assessment (PG-SGA) score ≥4
- Provided written informed consent
You will not qualify if you...
- Expected survival time less than 3 months
- Currently receiving or expected to receive anti-tumor therapy
- Presence of ascites or edema caused by malnutrition
- Known organic gastrointestinal diseases like infection, inflammatory bowel disease, or radiation enteritis
- History of gastrointestinal surgery other than appendectomy or anal fistula surgery
- Contraindications to enteral nutrition such as ileus, active gastrointestinal bleeding, or shock
- Unable to tolerate gastroscopy or colonoscopy
- Severe comorbidities including diabetes, cardiopulmonary failure, severe liver or kidney diseases
- Other wasting diseases such as active tuberculosis, hyperthyroidism, HIV, active hepatitis, hip fracture, or craniocerebral injury
- Anti-infective treatment within 30 days before enrollment or need for anti-infective treatment at enrollment
- Unwillingness to stop drugs affecting gut microbes such as probiotics
- Unable to tolerate oral enteral nutrition
- Pregnant or breastfeeding women
- Participation in another clinical trial
- Deemed unsuitable for inclusion by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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