An observational study in Gastroptosis and Malnutrition, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by The Second Hospital of Nanjing Medical University · Observational
This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 24 is below the median of 203 across 388 observational studies indexed under Malnutrition.
Browse Malnutrition studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 67 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients ≥18 years old with malnutrition and gastroptosis
Subjects must meet all of the following inclusion criteria to enter the study:
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);
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
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.
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.
Time frame: baseline, 12 weeks post transplantation
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.
Time frame: baseline, 12 weeks post transplantation
change of weight and height
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 12 weeks post transplantation
change of albumin and Prealbumin
Blood is tested for albumin and Prealbumin.
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: 12 weeks post transplantation
Plan to share: No
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The Second Hospital of Nanjing Medical University