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

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 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.

Conditions3

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