Washed Microbiota Transplantation for Malnutrition After Upper Gastrointestinal Rerouting Surgery

Sponsor

The Second Hospital of Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05439135

Collaborator

Sir Run Run Hospital, Nanjing Medical University (Other), Wuxi No. 2 People's Hospital (Other), The First Affiliated Hospital of Guangdong Pharmaceutical University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition Upper Gastrointestinal Rerouting Surgery	Other: washed microbiota transplantation	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: midgut 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 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. Other Names: partial enteral nutrition
Experimental: colonic A soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel.	Other: washed microbiota transplantation 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. Other Names: partial enteral nutrition

Arm

Intervention/Treatment

Experimental: midgut

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

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.

Other Names:

partial enteral nutrition

Experimental: colonic

A soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel.

Other: washed microbiota transplantation

Other Names:

partial enteral nutrition

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.