RecruitingNCT06837194

Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis

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

Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

24 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Malnutrition Gastroptosis

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria6

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 Criteria11

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.