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.
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
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Faming Zhang, +86-25-56662093, fzhang@njmu.edu.cn
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.
- Conditions
- Malnutrition, Gastroenterostomy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: washed microbiota transplantation |
| colonic | Experimental | A 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.
Changes of weight and height
Weight and height will be combined to report BMI in kg/m^2.
Measured: 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.
Measured: baseline, 8 weeks post transplantation
Changes of weight
Measured: baseline, 8 weeks post transplantation
Secondary outcomes (17)
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
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
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
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
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
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
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
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
Change of insulin-like growth factor I(IGF-I)
Blood is tested for Insulin-like growth factor I.
Measured: baseline, 8 weeks post transplantation
Changes of hemoglobin
Blood is tested for hemoglobin
Measured: baseline, 8 weeks post transplantation
Changes of albumin
Blood is tested for albumin
Measured: baseline, 8 weeks post transplantation
Changes of prealbumin
Blood is tested for prealbumin
Measured: baseline, 8 weeks post transplantation
Changes of cholesterol
Blood is tested for cholesterol
Measured: baseline, 8 weeks post transplantation
Changes of transferrin
Blood is tested for transferrin
Measured: baseline, 8 weeks post transplantation
Changes of C-reactive protein
Blood is tested for C-reactive protein
Measured: baseline, 8 weeks post transplantation
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
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.
- First posted30 Jun 2022
- Study start20 Oct 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangdong Pharmaceutical University, Nanjing Medical University, Wuxi No. 2 People's Hospital, Jiangxi University of Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The Affiliated Hospital Of Southwest Medical University, Tang-Du Hospital, Huzhou Central Hospital, West China Fourth Hospital, The Affiliated People's Hospital of Ningbo University, Guangzhou First People Hospital of Guangzhou Medical University, The First Affiliated Hospital of Anhui University of Chinese Medicine, Beijing Rectum Hospital, Dazhou Central Hospital, The Second Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Guangzhou Medical University, PLA No. 901 Hospital of the Joint Support Force, YI'AN PEOPLE'S HOSPITAL, Hunan Aerospace Hospital, Jiamusi City Hospital of Traditional Chinese Medicine, The First People's Hospital of Kunshan, LanZhou University, Jingxing xian yiyuan, TAIHE country people's hospital, Tailai County People's Hospital, Armed Police Characteristic Medical Center, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
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 19212169Nishizaki 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 34523717Zhang 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 23160295Xiang 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 34746161Levine 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 31170412Peng 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05439135
- Acronym / sponsor ID
- DELIV2022N002
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangdong Pharmaceutical University, Nanjing Medical University, Wuxi No. 2 People's Hospital, Jiangxi University of Chinese Medicine Affiliated Hospital, Hubei Hospital of Traditional Chinese Medicine, The Affiliated Hospital Of Southwest Medical University, Tang-Du Hospital, Huzhou Central Hospital, West China Fourth Hospital, The Affiliated People's Hospital of Ningbo University, Guangzhou First People Hospital of Guangzhou Medical University, The First Affiliated Hospital of Anhui University of Chinese Medicine, Beijing Rectum Hospital, Dazhou Central Hospital, The Second Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Guangzhou Medical University, PLA No. 901 Hospital of the Joint Support Force, YI'AN PEOPLE'S HOSPITAL, Hunan Aerospace Hospital, Jiamusi City Hospital of Traditional Chinese Medicine, The First People's Hospital of Kunshan, LanZhou University, Jingxing xian yiyuan, TAIHE country people's hospital, Tailai County People's Hospital, Armed Police Characteristic Medical Center, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midgut | Experimental | Other: washed microbiota transplantationA 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. |
| colonic | Experimental | Other: washed microbiota transplantationA soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| washed microbiota transplantationAlso: home enteral nutritionEach 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 | colonic, midgut |
Primary outcome
Changes of weight and height
Time frame: baseline, 8 weeks post transplantation
Weight and height will be combined to report BMI in kg/m^2.
Changes of the third lumbar vertebrae skeletal muscle mass and height
Time frame: baseline, 8 weeks post transplantation
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.
Changes of weight
Time frame: baseline, 8 weeks post transplantation
17 secondary outcomes
Changes of Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: baseline, 8 weeks post transplantation
Changes of the Gastrointestinal Symptom Rating Scale(GSRS)
Time frame: baseline, 4 weeks, 8 weeks post transplantation
60-day readmission rate
Time frame: From enrollment to the end of treatment at 8 weeks
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time frame: From enrollment to the end of treatment at 8 weeks
Changes of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)
Time frame: baseline, 4 weeks, 8 weeks post transplantation
Changes of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, 4 weeks, 8 weeks post transplantation
Changes of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time frame: baseline, 4 weeks, 8 weeks post transplantation
The difference of the gut microbiota composition before and after washed microbiota transplantation
Time frame: baseline, 8 weeks post transplantation
Change of insulin-like growth factor I(IGF-I)
Time frame: baseline, 8 weeks post transplantation
Changes of hemoglobin
Time frame: baseline, 8 weeks post transplantation
Changes of albumin
Time frame: baseline, 8 weeks post transplantation
Changes of prealbumin
Time frame: baseline, 8 weeks post transplantation
Changes of cholesterol
Time frame: baseline, 8 weeks post transplantation
Changes of transferrin
Time frame: baseline, 8 weeks post transplantation
Changes of C-reactive protein
Time frame: baseline, 8 weeks post transplantation
Changes of full spectrum of bile acidsare
Time frame: baseline, 8 weeks post transplantation
Changes of glucose breath testing
Time frame: baseline, 8 weeks post transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 19212169Csendes 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.
- Background: PubMed 34523717Nishizaki 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.
- Background: PubMed 23160295Zhang 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.
- Background: PubMed 34746161Xiang 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.
- Background: PubMed 31170412Levine 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.
- Background: PubMed 27556065Peng 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
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.