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Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract

RecruitingNAAges 18 Years - anyAllThe Second Hospital of Nanjing Medical University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • washed microbiota transplantation
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Where

1 site
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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