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MalnutritionNCT05439135

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

A study testing washed microbiota transplantation in people with Malnutrition and Gastroenterostomy, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malnutrition, Gastroenterostomy
What is being tested?
washed microbiota transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
20 Oct 2024to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Faming Zhang, +86-25-56662093, fzhang@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, Randomized Clinical Trial for Malnutrition After Nonphysiological Reconstruction of the Upper Gastrointestinal Tract: Washed Microbiota Transplantation Via Mid-gut Tube Versus Colonic Transendoscopic Enteral Tube

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.

Read the detailed description

Background: Malnutrition is a common complication of nonphysiological reconstruction of the upper gastrointestinal tract. 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 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.

Being tested
washed microbiota transplantation
Keywords
washed microbiota transplantation, fecal microbiota transplant, malnutrition, enteral nutrition, cachexia, upper gastrointestinal rerouting surgery, delivery, nonphysiological reconstruction of the upper gastrointestinal tract
Medical subject headings
Malnutrition, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • washed microbiota transplantationOther

    Also called home enteral nutrition

    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.

Study groups in NCT05439135
Study groupRoleWhat they receive
midgutExperimentalA 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.
Receives: Other: washed microbiota transplantation
colonicExperimentalA soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel.
Receives: Other: washed microbiota transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of weight and height

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

    Measured: baseline, 8 weeks post transplantation

  2. 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.

    Measured: baseline, 8 weeks post transplantation

  3. Changes of weight

    Measured: baseline, 8 weeks post transplantation

Secondary outcomes (17)

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

    Patient-Generated Subjective Global Assessment (PG-SGA) includes patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function) and the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam).

    Measured: baseline, 8 weeks post transplantation

  2. Changes of the Gastrointestinal Symptom Rating Scale(GSRS)

    GSRS is a 13-item test to make a comprehensive assessment of common gastrointestinal symptom and each item receives a value from 0 to 3, with higher value indicating worse gastrointestinal condition.

    Measured: baseline, 4 weeks, 8 weeks post transplantation

  3. 60-day readmission rate

    The 60-day readmission is recorded and defined as nonelective readmission within 60 days after the treatment.

    Measured: From enrollment to the end of treatment at 8 weeks

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

    The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).

    Measured: From enrollment to the end of treatment at 8 weeks

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

    EQ-5D-5L is a 5-dimension questionnaire measuring health state and each dimension represents the level from 1 to 5, with higher level indicating worse health state.

    Measured: baseline, 4 weeks, 8 weeks post transplantation

  6. Changes of the Pittsburgh Sleep Quality Index (PSQI)

    PSQI is a self-rated questionnaire which assesses sleep quality over a 1-month time interval. Nineteen items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for seven components yields one global score, with higher score indicating worse sleep quality.

    Measured: baseline, 4 weeks, 8 weeks post transplantation

  7. Changes of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    FACIT-Fatigue is a 13-item test measuring fatigue and each item receives a value from 0 to 4, with higher value indicating worse fatigue state.

    Measured: baseline, 4 weeks, 8 weeks post transplantation

  8. The difference of the gut microbiota composition before and after washed microbiota transplantation

    The composition of the gut microbiota is evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism.

    Measured: baseline, 8 weeks post transplantation

  9. Change of insulin-like growth factor I(IGF-I)

    Blood is tested for Insulin-like growth factor I.

    Measured: baseline, 8 weeks post transplantation

  10. Changes of hemoglobin

    Blood is tested for hemoglobin

    Measured: baseline, 8 weeks post transplantation

  11. Changes of albumin

    Blood is tested for albumin

    Measured: baseline, 8 weeks post transplantation

  12. Changes of prealbumin

    Blood is tested for prealbumin

    Measured: baseline, 8 weeks post transplantation

  13. Changes of cholesterol

    Blood is tested for cholesterol

    Measured: baseline, 8 weeks post transplantation

  14. Changes of transferrin

    Blood is tested for transferrin

    Measured: baseline, 8 weeks post transplantation

  15. Changes of C-reactive protein

    Blood is tested for C-reactive protein

    Measured: baseline, 8 weeks post transplantation

  16. Changes of full spectrum of bile acidsare

    Blood is tested for full spectrum of bile acidsare, including Cholic acid, deoxycholic acid, chenodeoxycholic acid, urs/hyodeoxycholic acid, lithocholic acid, glycocholic acid, glycolithocholic acid, glycodeoxycholic acid, glycochenodeoxycholic acid, glycouran Deoxycholic acid, taurocholic acid, taurolithocholic acid, taurodeoxycholic acid, taurochenodeoxycholic acid, tauroursodeoxycholic acid.

    Measured: baseline, 8 weeks post transplantation

  17. Changes of glucose breath testing

    A baseline breath sample was obtained, patients drank 50g glucose dissolved in 8 ounces of water, and breath samples were obtained at 15-minute intervals for 2 hours. Samples were analyzed to calculate breath H2 and/or breath CH4.

    Measured: baseline, 8 weeks post transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2022
  2. Study start20 Oct 2024
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05439135
Sponsor's protocol ID
DELIV2022N002
Status last verified
Oct 2024
First submitted
19 Jun 2022
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 19212169

  • 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.

    PubMed 34523717

  • 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.

    PubMed 23160295

  • 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.

    PubMed 34746161

  • 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.

    PubMed 31170412

  • 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.

    PubMed 27556065

Questions about this trial

What is this clinical trial studying?

A study testing washed microbiota transplantation in people with Malnutrition and Gastroenterostomy, run by The Second Hospital of Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of weight and height (time frame: baseline, 8 weeks post transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05439135, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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