Transplanting washed microbiota with nutritional support for gastroptosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the efficacy and safety of washed microbiota transplantation (WMT) combined with enteral nutrition in patients diagnosed with gastroptosis and malnutrition. Participants will be monitored for their response to this combined treatment approach. The study will include adults who meet specific diagnostic criteria for gastroptosis and malnutrition, ensuring a focused examination of this patient population. The study will be conducted at The Second Hospital of Nanjing Medical University.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Faming Zhang — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, PhD
• Email: fzhang@njmu.edu.cn
• Phone: 086-025-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.