Gastroptosis, Malnutrition
Conditions
Keywords
washed microbiota transplantation, microbiota medicine, Gastroptosis, malnutrition, enteral nutrition, Transendoscopic Enteral Tubing
Brief summary
This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients
Interventions
None listed
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must meet all of the following inclusion criteria to enter the study: 1. Clinically diagnosed with gastroptosis; 2. 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); * Low BMI (BMI \<18.5 kg/m² for individuals \<70 years old; BMI \<20 kg/m² for individuals ≥70 years old); 3. Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years; 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of gastroptosis with degree relief after the procedure. | baseline, 12 weeks post transplantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of weight and height | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | Weight and height will be combined to report BMI in kg/m\^2. |
| change of the Gastrointestinal Symptom Rating Scale(GSRS) | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| 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) | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| change of the Pittsburgh Sleep Quality Index (PSQI) | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| The extent of change observed in gastrointestinal ultrasound (GIUS) of participants | baseline, 12 weeks post transplantation | The half gastric emptying time will be evaluated by GIUS. |
| change of the third lumbar vertebrae skeletal muscle mass and height | baseline, 12 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. |
| change of the Hamilton Anxiety Scale(HAMA) | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| change of the Hamilton Depression Scale(HAMD） | baseline, 4 weeks, 8 weeks, 12 weeks post transplantation | 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. |
| change of insulin-like growth factor I(IGF-I) | baseline, 12 weeks post transplantation | Blood is tested for Insulin-like growth factor I. |
| change of albumin and Prealbumin | baseline, 12 weeks post transplantation | Blood is tested for albumin and Prealbumin. |
| change of cytokine | baseline, 12 weeks post transplantation | 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. |
| The changes in gut microbiota composition and metabolites before and after treatment | baseline, 12 weeks post transplantation | The 16s-RNA or meta-analysis of gut microbiota will be used. |
| the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | 12 weeks post transplantation | 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.). |
| The extent of change observed in transcranial Doppler (TCD) of participants | baseline, 12 weeks post transplantation | 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. |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui, PhD
Outcome results
None listed