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Clinical Trials/NCT06837194
NCT06837194RecruitingNot Applicable

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

The Second Hospital of Nanjing Medical University1 site in 1 country24 target enrollmentStarted: February 1, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
The proportion of gastroptosis with degree relief after the procedure.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

The proportion of gastroptosis with degree relief after the procedure.

Time Frame: baseline, 12 weeks post transplantation

Detailed evaluation content of efficacy rate of degree: The ultrasound examination was divided into three levels of light, medium and heavy according to the specific value of the middle gastric angle below Iliac spines are connected, defined as a reduction of at least 50% in value or a reduction of degree.

Secondary Outcomes

  • The extent of change observed in gastrointestinal ultrasound (GIUS) of participants(baseline, 12 weeks post transplantation)
  • change of the third lumbar vertebrae skeletal muscle mass and height(baseline, 12 weeks post transplantation)
  • change of weight and height(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • change of the Gastrointestinal Symptom Rating Scale(GSRS)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • The results of gastric fitted emptying rate data for 2 hours or 4 hours in the gastric emptying experiment with nuclide imaging(baseline, 12 weeks post transplantation)
  • change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • change of the Pittsburgh Sleep Quality Index (PSQI)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • The extent of change observed in transcranial Doppler (TCD) of participants(baseline, 12 weeks post transplantation)
  • change of the Hamilton Anxiety Scale(HAMA)(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • change of the Hamilton Depression Scale(HAMD）(baseline, 4 weeks, 8 weeks, 12 weeks post transplantation)
  • change of insulin-like growth factor I(IGF-I)(baseline, 12 weeks post transplantation)
  • change of albumin and Prealbumin(baseline, 12 weeks post transplantation)
  • change of cytokine(baseline, 12 weeks post transplantation)
  • The changes in gut microbiota composition and metabolites before and after treatment(baseline, 12 weeks post transplantation)
  • the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(12 weeks post transplantation)

Investigators

Sponsor
The Second Hospital of Nanjing Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Faming Zhang

Professor, Gastroenterology

The Second Hospital of Nanjing Medical University

Study Sites (1)

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