Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis

Recruiting now

Conditions studied: Gastroptosis, Malnutrition

In brief

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

Key facts

Study ID

NCT06837194

Run by

The Second Hospital of Nanjing Medical University

People needed

24

Starts

2025-02-01

Expected to finish

2027-07-01

Last updated by the study team

2025-02-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.