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This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Group | Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive three doses of WMT and enteral nutrition for three months for gastroptosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of gastroptosis with degree relief after the procedure. | Detailed evaluation content of efficacy rate of degree: The ultrasound examination was divided into three levels of light, medium and heavy according to the specific value of the middle gastric angle below Iliac spines are connected, defined as a reduction of at least 50% in value or a reduction of degree. | baseline, 12 weeks post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| change 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. |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to enter the study:
Clinically diagnosed with gastroptosis;
Meets the diagnostic criteria for malnutrition (fulfilling any one of the following two criteria):
Weight loss (weight loss >5% within the last 6 months or >10% over more than 6 months);
Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years;
Willing to voluntarily sign a written informed consent form and agrees to follow medical advice for regular follow-up examinations and monitoring after the completion of treatment.
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
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Patients ≥18 years old with malnutrition and gastroptosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faming Zhang, PhD | Contact | 086-025-58509883 | fzhang@njmu.edu.cn | |
| Bota Cui, PhD | Contact | 086-025-58509884 | cuibota@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Faming Zhang | The Second Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29691757 | Background | Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24. | |
| 26526081 | Background | Quince C, Ijaz UZ, Loman N, Eren AM, Saulnier D, Russell J, Haig SJ, Calus ST, Quick J, Barclay A, Bertz M, Blaut M, Hansen R, McGrogan P, Russell RK, Edwards CA, Gerasimidis K. Extensive Modulation of the Fecal Metagenome in Children With Crohn's Disease During Exclusive Enteral Nutrition. Am J Gastroenterol. 2015 Dec;110(12):1718-29; quiz 1730. doi: 10.1038/ajg.2015.357. Epub 2015 Nov 3. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Feces, urine and blood
| baseline, 12 weeks post transplantation |
| change of weight and height | Weight and height will be combined to report BMI in kg/m^2. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| change 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. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants | The GCSI consists of nine items and three subscales to measure symptoms related to gastroparesis. The nausea/vomiting subscale consists of the following three items: nausea, retching, and vomiting. The postprandial fullness/early satiety subscale consists of the following four items: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| The results of gastric fitted emptying rate data for 2 hours or 4 hours in the gastric emptying experiment with nuclide imaging | baseline, 12 weeks post transplantation |
| change 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. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| change 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. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| change 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. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| The extent of change observed in gastrointestinal ultrasound (GIUS) of participants | The half gastric emptying time will be evaluated by GIUS. | baseline, 12 weeks post transplantation |
| The extent of change observed in transcranial Doppler (TCD) of participants | TCD was used to evaluate the degree of continuity of echo in the nucleus suture in patients, and echoic discontinuity represented the possibility of anxiety and depression. | baseline, 12 weeks post transplantation |
| change of the Hamilton Anxiety Scale(HAMA) | Hamilton Anxiety Scale is a 14-item test measuring anxiety and each item receives a value from 0 to 4, with higher value indicating worse anxiety state. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| change of the Hamilton Depression Scale(HAMD） | Hamilton Depression Scale is a 17-item test measuring depression and each item receives a value from 0 to 4, with higher value indicating worse depression state. | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation |
| change of insulin-like growth factor I(IGF-I) | Blood is tested for Insulin-like growth factor I. | baseline, 12 weeks post transplantation |
| change of albumin and Prealbumin | Blood is tested for albumin and Prealbumin. | baseline, 12 weeks post transplantation |
| change of cytokine | Blood is tested for IL-1β、IL-2、IL-4、IL-5、IL-6、IL-8、IL-10、IL-12p70、IL-17、TNF-α、IFN-γ、IFN-α. | baseline, 12 weeks post transplantation |
| The changes in gut microbiota composition and metabolites before and after treatment | The 16s-RNA or meta-analysis of gut microbiota will be used. | baseline, 12 weeks post transplantation |
| 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.). | 12 weeks post transplantation |
|
| 32289543 | Background | Fernandes ND, Murphy SA. Gastroptosis: An Uncommon Cause for a Deep Nasogastric Tube. Clin Gastroenterol Hepatol. 2021 Jun;19(6):A23. doi: 10.1016/j.cgh.2020.04.016. Epub 2020 Apr 11. No abstract available. |
| 37804872 | Background | Xu LC, Garcia JC. Gastroptosis in a young woman. Gastrointest Endosc. 2024 Mar;99(3):454-455. doi: 10.1016/j.gie.2023.10.006. Epub 2023 Oct 5. No abstract available. |
| 27556065 | Result | 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. |
| 34746161 | Result | 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. |