Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract
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
The Second Hospital of Nanjing Medical University
62 participants
Oct 20, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- 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 Criteria14
- 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.
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Interventions
Each patient will receive washed microbiota transplantation each day for three consecutive days. After WMT, participants will receive free diet plus home enteral nutrition (solution at a 750ml daily dosage that provides 750 kcal energy) at home for 8 weeks.
Locations(1)
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NCT05439135