Washed microbiota transplantation for malnutrition after upper gastrointestinal reconstruction

An Open-label, Multicenter, Randomized Clinical Trial for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract: Washed Microbiota Transplantation Via Mid-gut Tube Versus Colonic Transendoscopic Enteral Tube

This trial will test whether washed microbiota transplantation delivered through the small intestine or the colon helps adults with malnutrition after nonphysiological reconstruction of the upper digestive tract.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05439135 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label randomized study will enroll 62 adults with malnutrition after nonphysiological reconstruction of the upper gastrointestinal tract across 14 hospitals in China. Participants are randomized 1:1 to receive three washed microbiota transplantations delivered either by mid-gut tube or by colonic transendoscopic enteral tubing (TET), followed by a free diet plus home enteral nutrition for 8 weeks. Primary outcomes are changes in nutritional status including BMI and skeletal muscle index measured at baseline and 8 weeks, with secondary outcomes including laboratory nutrition markers, quality of life, gastrointestinal symptoms, 60-day readmission, and safety. Blood, urine, and stool samples are collected and stored at baseline and 2 months to support mechanistic and safety analyses.

Who should consider this trial

Good fit: Adults over 18 with malnutrition after nonphysiological upper GI reconstruction (for example Billroth-II, Roux-en-Y, Child, or Whipple), with NRS-2002 ≥3 and PG-SGA ≥4, able to tolerate endoscopy and with expected survival beyond 3 months.

Not a fit: Patients currently on or expected to start anti-tumor therapy, those with ascites or edema from malnutrition, active organic gastrointestinal disease, contraindications to enteral nutrition, severe comorbidities, or expected survival under 3 months are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could speed nutritional recovery, increase muscle mass, and reduce readmissions for patients who became malnourished after upper GI reconstruction.

How similar studies have performed: Small reports and observational studies suggest washed microbiota transplantation can improve nutritional measures, but randomized multicenter data—especially comparing delivery routes—are limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Nanjing, Jiangsu

• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Conditions Malnutrition; Gastroenterostomy; washed microbiota transplantation; fecal microbiota transplant; malnutrition; enteral nutrition; cachexia; upper gastrointestinal rerouting surgery