An interventional study of washed microbiota transplantation in Malnutrition and Gastroenterostomy, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
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Among 59 studies in Malnutrition with a site in China — 20 open to participants now, 21 under way, 1 of them phase 3. Malnutrition · China.
Among the 59 studies in Malnutrition with a site in China, this one is the 27th largest by planned enrollment of the 32 interventional ones that give a count, is one of 6 that started in 2024, is one of 19 with no phase, reaches primary completion later than 3 of the 20 other live ones, and was the 35th registered.
1,278 studies on the registry are indexed under Malnutrition; 231 are open to participants now.
Browse Malnutrition studies →20 of the 59 studies in Malnutrition with a site in China are open now. Recruiting first, the newest first:
Huashan Hospital · Sites in China
Ages 61+
The Second Hospital of Nanjing Medical University · Sites in China
Ages 18–100
Xiaoqin Luo · Sites in China
Ages 18+
Chengdu Qingshan Likang Pharmaceutical Co., Ltd · Sites in China
Ages 18–75
Children's Hospital of Chongqing Medical University · Sites in China
Ages 1–3
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 149 Malnutrition studies recruiting now, 84 (56%) set no upper age limit and 45 (30%) stop at 75 or younger; 40 take children under 18; 28 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 6 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 62 is below the median of 118 across 844 interventional studies indexed under Malnutrition.
Median enrollment 120 across the 32 interventional studies, 500 across the 27 observational. Of the 24 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 59 have an industry lead sponsor. The 10 most frequent:
The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
The Second Hospital of Nanjing Medical University has 4 studies filed under Malnutrition — fewer than ten, so there is no comparison to draw.
5 of the studies in Malnutrition with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05242055Capital Medical UniversityIntegrated Diagnosis and Treatment of CKD on Outcomes | 2026-12-31 |
| NCT06837194The Second Hospital of Nanjing Medical UniversityWashed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis | 2027-02-01 |
| NCT07136727The First Affiliated Hospital of Xinxiang Medical CollegeAI-Assisted Comprehensive Management for Cancer Patients With Comorbidities (GCOG-CG001) | 2027-05-01 |
| NCT07565415Nanfang Hospital, Southern Medical UniversityNanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy | 2027-09-01 |
| NCT07850375Institute of Hematology & Blood Diseases Hospital, ChinaNutritional Intervention for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation | 2027-10-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 59 studies in Malnutrition with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
A soft TET tube is inserted into the colon via the paraffin-lubricated colonoscope channel.
Other: 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.
Also known as: home enteral nutrition
Changes of weight and height
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 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.
Time frame: baseline, 8 weeks post transplantation
Changes of weight
Time frame: baseline, 8 weeks post transplantation
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).
Time frame: 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.
Time frame: 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.
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
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.).
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 8 weeks post transplantation
Change of insulin-like growth factor I(IGF-I)
Blood is tested for Insulin-like growth factor I.
Time frame: baseline, 8 weeks post transplantation
Changes of hemoglobin
Blood is tested for hemoglobin
Time frame: baseline, 8 weeks post transplantation
Changes of albumin
Blood is tested for albumin
Time frame: baseline, 8 weeks post transplantation
Changes of prealbumin
Blood is tested for prealbumin
Time frame: baseline, 8 weeks post transplantation
Changes of cholesterol
Blood is tested for cholesterol
Time frame: baseline, 8 weeks post transplantation
Changes of transferrin
Blood is tested for transferrin
Time frame: baseline, 8 weeks post transplantation
Changes of C-reactive protein
Blood is tested for C-reactive protein
Time frame: 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.
Time frame: 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.
Time frame: baseline, 8 weeks post transplantation
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 12 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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The Second Hospital of Nanjing Medical University