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

NCT05439135 | Recruiting DMC

• 1 other identifier: DELIV2022N002
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition; Gastroenterostomy

Keywords

washed microbiota transplantation; fecal microbiota transplant; malnutrition; enteral nutrition; cachexia; upper gastrointestinal rerouting surgery; delivery; nonphysiological reconstruction of the upper gastrointestinal tract

Outcome Measures

Primary Outcomes (3)

• Changes of weight and height

  Weight and height will be combined to report BMI in kg/m\^2.

  baseline, 8 weeks post transplantation

• Changes of the third lumbar vertebrae skeletal muscle mass and height

  The third lumbar vertebrae skeletal muscle mass represents the sum of the cross-sectional areas of the skeletal muscles at the L3 level, including the psoas major, the erector spinae, the quadratus lumborum, the musculus transversus abdominis, the obliquus externus abdominis and the obliquus internus abdominis. Skeletal muscle mass and height will be combined to report the third lumbar vertebrae skeletal muscle mass index(L3 SMI) in cm\^2/m\^2.

  baseline, 8 weeks post transplantation

• Changes of weight

  baseline, 8 weeks post transplantation

Secondary Outcomes (17)

• Changes of Patient-Generated Subjective Global Assessment (PG-SGA)

  baseline, 8 weeks post transplantation

• Changes of the Gastrointestinal Symptom Rating Scale(GSRS)

  baseline, 4 weeks, 8 weeks post transplantation

• 60-day readmission rate

  From enrollment to the end of treatment at 8 weeks

• The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0

  From enrollment to the end of treatment at 8 weeks

• Changes of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)

  baseline, 4 weeks, 8 weeks post transplantation

Study Arms (2)

midgut

EXPERIMENTAL

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

colonic

EXPERIMENTAL

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

Other: washed microbiota transplantation

Interventions

washed microbiota transplantation OTHER

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.

Also known as: home enteral nutrition

colonic; midgut

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• The First Affiliated Hospital of Guangdong Pharmaceutical University: collaborator
• Nanjing Medical University: collaborator
• Wuxi No. 2 People's Hospital: collaborator
• Jiangxi University of Chinese Medicine Affiliated Hospital: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• Tang-Du Hospital: collaborator
• Huzhou Central Hospital: collaborator
• West China Forth University Hospital，Sichuan University: collaborator
• The Affiliated People's hospital of Ningbo Univercity: collaborator
• Guangzhou First People Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital of Anhui University of Chinese Medicine: collaborator
• Beijing Rectum Hospital: collaborator
• Dazhou Central Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• The 901th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army: collaborator
• YI'AN PEOPLE'S HOSPITAL: collaborator
• Hunan Aerospace Hospital: collaborator
• Jiamusi City Hospital of Traditional Chinese Medicine: collaborator
• The First People's Hospital of Kunshan: collaborator
• LanZhou University: collaborator
• Jingxing xian yiyuan: collaborator
• TAIHE country people's hospital: collaborator
• Tailai County People's Hospital: collaborator
• Armed Police Characteristic Medical Center: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (6)

• Csendes A, Burgos AM, Smok G, Burdiles P, Braghetto I, Diaz JC. Latest results (12-21 years) of a prospective randomized study comparing Billroth II and Roux-en-Y anastomosis after a partial gastrectomy plus vagotomy in patients with duodenal ulcers. Ann Surg. 2009 Feb;249(2):189-94. doi: 10.1097/SLA.0b013e3181921aa1.

  PMID: 19212169 BACKGROUND

• Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.

  PMID: 34523717 BACKGROUND

• Zhang F, Luo W, Shi Y, Fan Z, Ji G. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol. 2012 Nov;107(11):1755; author reply p.1755-6. doi: 10.1038/ajg.2012.251. No abstract available.

  PMID: 23160295 BACKGROUND

• Xiang L, Yu Y, Ding X, Zhang H, Wen Q, Cui B, Zhang F. Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation in Crohn's Disease With Malnutrition: A Randomized Pilot Study. Front Med (Lausanne). 2021 Oct 22;8:666062. doi: 10.3389/fmed.2021.666062. eCollection 2021.

  PMID: 34746161 BACKGROUND

• Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.

  PMID: 31170412 BACKGROUND

• Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.

  PMID: 27556065 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Gastroenterology

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 30, 2022
• Study Start: October 20, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: July 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)