Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT06837194
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06837194
Study Brief:
Protocol Section:
NCT06837194