Washed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Feb 15, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients suffering from gastroptosis, a condition where the stomach is positioned lower than normal, which can lead to malnutrition. The study is looking at the combination of washed microbiota transplantation (WMT) and enteral nutrition, which involves feeding through a tube, to see how effective and safe this treatment is for improving the health of these patients. The trial is currently recruiting participants aged 18 and older who have been diagnosed with gastroptosis and meet certain criteria for malnutrition, such as significant weight loss or a low body mass index (BMI).

If you or a loved one is considering participating in this trial, there are a few key things to know. Eligible participants will need to be willing to follow medical advice and attend regular check-ups after treatment. However, individuals with severe mental health issues, certain heart or lung conditions, or active infections, among other serious health concerns, will not be able to join the study. Participants can expect to receive nutritional support along with the microbiota treatment and will be closely monitored throughout the trial to ensure their safety and progress.

Gender

ALL

Eligibility criteria

• 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.