Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorThe Second Hospital of Nanjing Medical University
About this trial
This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically diagnosed with gastroptosis;
Weight loss (weight loss >5% within the last 6 months or >10% over more than 6 months);
Low BMI (BMI <18.5 kg/m² for individuals <70 years old; BMI <20 kg/m² for individuals ≥70 years old);
Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years;
Disqualifiers
Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning;
Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition;
Anticipated survival time <3 months;
Clinically significant cardiovascular diseases, including heart failure (NYHA Class III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, history of myocardial infarction, hemodynamic instability at enrollment, unstable vital signs, or anticipated risk events during treatment;
Trial population
Patients ≥18 years old with malnutrition and gastroptosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
24 Participants
are grouped into 1 trial groupGroup A: Observation Group
Trial outcomes
Primary outcomes
1
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 transplantationSecondary outcomes
1
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 transplantation2
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 transplantation3
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 transplantation4
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 transplantationSponsors and contacts
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Source ClinicalTrials.gov