Washed Microbiota Transplantation for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract
NCT ID: NCT05439135
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-10-20
2025-10-31
Brief Summary
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Detailed Description
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Methods and design: This multicenter, open-label, and randomized controlled trial will be conducted at forteen 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 home enteral nutrition (HEN) for 8 weeks in both groups, with blood, urine and stool samples taken and stored at baseline and 2 months after WMT. The observation duration is 8 weeks. The primary endpoint is nutritional status of the patients. The nutritional status data obtained at baseline and 8 weeks after discharge includes body mass index (BMI) and skeletal muscle index (SMI). The secondary endpoints are nutritional assessment, nutrition-based laboratory indices, 60-day readmission rate, quality of life, gastrointestinal symptom scale, the safety of WMT and further analysis of the biological specimens.
Conclusion: It is estimated that WMT would help improve nutrition status. Moreover, this trial has the potential to identify the optimal delivery of WMT for patients undergoing nonphysiological reconstruction of the upper gastrointestinal tract.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
washed microbiota transplantation
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.
colonic
A soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel.
washed microbiota transplantation
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.
Interventions
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washed microbiota transplantation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Guangdong Pharmaceutical University
OTHER
Nanjing Medical University
OTHER
Wuxi No. 2 People's Hospital
OTHER
Jiangxi University of Chinese Medicine Affiliated Hospital
UNKNOWN
Hubei Hospital of Traditional Chinese Medicine
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
Tang-Du Hospital
OTHER
Huzhou Central Hospital
OTHER
West China Forth University Hospital，Sichuan University
UNKNOWN
The Affiliated People's hospital of Ningbo Univercity
OTHER
Guangzhou First People Hospital of Guangzhou Medical University
UNKNOWN
The First Affiliated Hospital of Anhui University of Chinese Medicine
OTHER
Beijing Rectum Hospital
UNKNOWN
Dazhou Central Hospital
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
The 901th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
UNKNOWN
YI'AN PEOPLE'S HOSPITAL
UNKNOWN
Hunan Aerospace Hospital
UNKNOWN
Jiamusi City Hospital of Traditional Chinese Medicine
UNKNOWN
The First People's Hospital of Kunshan
OTHER
LanZhou University
OTHER
Jingxing xian yiyuan
UNKNOWN
TAIHE country people's hospital
UNKNOWN
Tailai County People's Hospital
UNKNOWN
Armed Police Characteristic Medical Center
UNKNOWN
First Affiliated Hospital Xi'an Jiaotong University
OTHER
The Second Hospital of Nanjing Medical University
OTHER
Responsible Party
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Faming Zhang
Associate professor, Gastroenterology
Locations
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The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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DELIV2022N002
Identifier Type: -
Identifier Source: org_study_id
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