Transplanting washed microbiota with nutritional support for gastroptosis
The Efficacy of WMT Combined With Nutritional Support in the Treatment of Malnutrition Complicated by Gastroptosis: A Real-World Study
This study is testing if a new treatment using washed microbiota along with special nutrition can help adults with gastroptosis and malnutrition feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jangsu) |
| Trial ID | NCT06837194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with gastroptosis and meeting malnutrition criteria.
Not a fit: Patients with severe mental health issues that impair communication and treatment planning may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve nutritional status and overall health outcomes for patients suffering from gastroptosis and malnutrition.
How similar studies have performed: While the approach of washed microbiota transplantation is gaining interest, its combination with enteral nutrition for gastroptosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.