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NCT Number: NCT06837194

Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis

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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Key information

Conditions

Gastroptosis Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jangsu, 210000, China

Location status: Recruiting

Location contact

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);
  • 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;
  • 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:
  • 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;
  • Poor pulmonary function deemed by investigators to impact study treatment (e.g., acute exacerbation of COPD or requirement for long-term oral/intravenous corticosteroids [excluding inhaled corticosteroids]);
  • Active severe clinical infections (> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections;
  • Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement;
  • Use of medications affecting or modulating gut microbiota within the past 48 hours;
  • Lack of legal capacity or restricted legal capacity;
  • Hematologic disorders unsuitable for blood draw examinations;
  • Other severe medical conditions deemed by investigators to preclude patient enrollment.

Treatment and study plan

Primary outcomes

  1. The proportion of gastroptosis with degree relief after the procedure.

    Time frame: 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 outcomes

  1. change of the third lumbar vertebrae skeletal muscle mass and height

    Time frame: 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.

  2. change of weight and height

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

    Weight and height will be combined to report BMI in kg/m^2.

  3. change of the Gastrointestinal Symptom Rating Scale(GSRS)

    Time frame: 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.

  4. The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants

    Time frame: 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.

  5. 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

  6. change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)

    Time frame: 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.

  7. change of the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  8. change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    Time frame: 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.

  9. The extent of change observed in gastrointestinal ultrasound (GIUS) of participants

    Time frame: baseline, 12 weeks post transplantation

    The half gastric emptying time will be evaluated by GIUS.

  10. The extent of change observed in transcranial Doppler (TCD) of participants

    Time frame: 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.

  11. change of the Hamilton Anxiety Scale(HAMA)

    Time frame: 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.

  12. change of the Hamilton Depression Scale(HAMD）

    Time frame: 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.

  13. change of insulin-like growth factor I(IGF-I)

    Time frame: baseline, 12 weeks post transplantation

    Blood is tested for Insulin-like growth factor I.

  14. change of albumin and Prealbumin

    Time frame: baseline, 12 weeks post transplantation

    Blood is tested for albumin and Prealbumin.

  15. change of cytokine

    Time frame: 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.

  16. The changes in gut microbiota composition and metabolites before and after treatment

    Time frame: baseline, 12 weeks post transplantation

    The 16s-RNA or meta-analysis of gut microbiota will be used.

  17. the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0

    Time frame: 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.).

Study contacts

Contact information is provided by the study sponsor or research team.

Bota Cui, PhD

CONTACT

[email protected]

086-025-58509884

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

The Efficacy of WMT Combined With Nutritional Support in the Treatment of Malnutrition Complicated by Gastroptosis: A Real-World Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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