Washed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis

Nanjing Medical University

Status: Enrolling

Conditions: Gastroptosis; Malnutrition

Study type: Observational

Funder types: Other

Identifiers

NCT06837194

WMT-gastroptosis

Details and patient eligibility

About

This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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 exclusion criteria must be excluded from the study:

  1. Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning;
  2. Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition;
  3. Anticipated survival time <3 months;
  4. 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;
  5. 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]);
  6. Active severe clinical infections (> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections;
  7. Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement;
  8. Use of medications affecting or modulating gut microbiota within the past 48 hours;
  9. Lack of legal capacity or restricted legal capacity;
  10. Hematologic disorders unsuitable for blood draw examinations;
  11. Other severe medical conditions deemed by investigators to preclude patient enrollment.

Trial design

24 participants in 1 patient group

Observation Group

Description:

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.