Washed Microbiota Transplantation for Malnutrition After Upper Gastrointestinal Rerouting Surgery

Study Overview
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Brief Summary
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This is a prospective, randomized, multicenter study to evaluate WMT in improving nutritional status in malnourished patients who underwent upper gastrointestinal rerouting surgery. In this multicenter trial, fifty-six patients will be enrolled in four 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 50% PEN. PEN should last for 4 weeks at home, with stool samples taken and stored at baseline, week 1, and 4 after WMT.

Detailed Description
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Background: Malnutrition is a common complication of upper gastrointestinal rerouting surgery. The potential of washed microbiota transplantation (WMT) in improving nutritional status have been reported. The surgery procedure alters the anatomy and physiology of the digestive tract, which might impact the efficacy and safety of WMT when choosing different delivery way. This study aims to explore the optimal delivery of WMT in malnourished patients after rerouting of the upper gastrointestinal tract. Methods and design: This multicenter, open-label, and randomized controlled trial will be conducted at four tertiary hospitals in China. Enteral nutrition (EN) will be administrated at enrollment. Participants will be then randomized at a ratio of 1:1 to receive three WMTs through either mid-gut tube or colonic transendoscopic enteral tubing (TET). Then the patients will receive free diet coupled with partial enteral nutrition (PEN) for 4 weeks in both groups, with stool samples taken and stored at baseline, week 1, and 4 after WMT. The observation duration is 4 weeks. The primary outcomes include clinical response rate (serum albumin ≥ 35 g/L at week 4 after WMT) and clinical remission rate (body mass index increased by 5% at week 4 after WMT). The secondary outcomes include nutritional status, appetite, laboratory parameters, adverse events and comprehensive analysis of the fecal microbiota. Conclusion: It is estimated that WMT would help relieve emaciation and improve nutrition status. Moreover, this trial has the potential to identify the optimal delivery of WMT for patients undergoing upper gastrointestinal rerouting surgery.

Official Title
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An Open-label, Multicenter, Randomized Clinical Trial for Malnutrition After Upper Gastrointestinal Rerouting Surgery: Washed Microbiota Transplantation Via Mid-gut Tube Versus Colonic Transendoscopic Enteral Tube

Conditions
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Malnutrition, Upper Gastrointestinal Rerouting Surgery

Intervention / Treatment
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* Other: washed microbiota transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergone upper gastrointestinal rerouting surgery (Billroth-II or Roux-en-Y reconstruction); Aged between 18 and 65 years old; Weight loss > 5% over past 6 months (in absence of simple starvation) or weight loss > 2% in those who have a BMI < 20; 20 g/L ≤ Albumin < 30 g/L; Malnutrition as assessed by NRS2002 score ≥ 3; Written informed consent. Exclusion Criteria: Expected survival time < 3 months; Known organic gastrointestinal disease (e.g., gastrointestinal infection, inflammatory bowel disease, or radiation enteritis); Still on anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy); Taking Antibiotics within four weeks before enrollment; Complicated with contraindications of EN such as ileus, active gastrointestinal bleeding, and shock; Cannot tolerate gastroscopy or colonoscopy; Severe comorbidities (e.g., diabetes, cardiopulmonary failure, severe liver or kidney diseases); Food intolerance; Mental disorder; Women who are pregnant or breastfeeding; Participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midgut<br>A soft TET tube is inserted into the colon via the paraffin-lubricated gastroscope channel. If patients cannot tolerate endoscopy or anesthesia, or it is difficult to confirm the bypass intestine under endoscopy, a nasojejunal tube will be inserted under digital fluoroscopy. | Other: washed microbiota transplantation<br>* Each patient will receive two units of washed microbiota each day for three consecutive days. After WMT, participants will receive free diet plus 50% PEN (providing 50% calculated energy requirement) at home for 4 weeks.<br>* Other names: partial enteral nutrition;|
| Experimental: colonic<br>A soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel. | Other: washed microbiota transplantation<br>* Each patient will receive two units of washed microbiota each day for three consecutive days. After WMT, participants will receive free diet plus 50% PEN (providing 50% calculated energy requirement) at home for 4 weeks.<br>* Other names: partial enteral nutrition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate | serum albumin ≥ 35 g/L | week 4 after WMT | 
| Clinical remission rate | body mass index (BMI) increased by 5% (weight and height will be combined to report BMI in kg/m^2) | week 4 after WMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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washed microbiota transplantation, fecal microbiota transplant, malnutrition, enteral nutrition, cachexia, upper gastrointestinal rerouting surgery, delivery