Washed Microbiota Transplantation for Malnutrition After Upper Gastrointestinal Rerouting Surgery

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05439135
• Other study ID #: DELIV2022N002
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2022
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	Sir Run Run Hospital, Nanjing Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Wuxi No. 2 People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Csendes A, Burgos AM, Smok G, Burdiles P, Braghetto I, Díaz 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. — View Citation

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. — View Citation

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:CD012998. doi: 10.1002/14651858.CD012998.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate	serum albumin = 35 g/L	week 4 after WMT
Primary	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