Clinical trial
Washed Microbiota Transplantation for Malnutrition
Name
WMT-MN-2024
Description
Malnutrition is a pathological condition in which dietary intake fails to meet the body's energetic or nutritional needs. It may be caused by macronutrient or micronutrient deficiencies, high energy expenditure, impaired nutrient absorption or assimilation. Malnutrition can affect all stages of life. In adults, malnutrition is strongly associated with poor clinical outcomes such as increased morbidity, increased mortality and prolonged hospitalization. In children, malnutrition can lead to growth retardation, cognitive impairment and immune dysfunction.
Trial arms
Trial start
2024-06-01
Estimated PCD
2030-12-01
Trial end
2031-04-01
Status
Recruiting
Treatment
washed microbiota transplantation
The prepared microbiota suspension was infused into the patients' gut.
Arms:
The malnourished undergoing washed microbiota transplantation
Other names:
fecal microbiota transplantation
Size
100
Primary endpoint
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
Eligibility criteria
Inclusion Criteria:
1. Age ≥18 years old;
2. Meet any of the following two conditions: ①weight loss (\>5% weight loss in the past 6 months or \>10% weight loss in more than 6 months); ②low BMI (\<70 years old and BMI\<18.5kg/m2 or ≥70 years old and BMI\<22kg/m2);
3. Underwent washed microbiota transplantation.
Exclusion Criteria:
1. Expected survival time \<3 months;
2. Women who are pregnant or breastfeeding;
3. Other patients deemed not suitable for enrollment by the investigator.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fecal, blood and urine samples before and 12 weeks after washed microbiota transplantation'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-06-07
1 organization