Washed Microbiota Transplantation for Malnutrition
ConditionMalnutrition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old;
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);
Underwent washed microbiota transplantation.
Disqualifiers
Expected survival time <3 months;
Women who are pregnant or breastfeeding;
Other patients deemed not suitable for enrollment by the investigator.
Trial population
Patients with malnutrition receiving WMT will be enrolled.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
washed microbiota transplantation
Procedure/SurgeryThe prepared microbiota suspension was infused into the patients' gut.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: The malnourished undergoing washed microbiota transplantation1 intervention
Group B: The malnourished not undergoing washed microbiota transplantation0 interventions
Trial outcomes
Primary outcomes
1
change of the third lumbar vertebrae skeletal muscle mass and height
The third lumbar vertebrae skeletal muscle mass represents the sum of the cross-sectional areas of the skeletal muscles at the L3 level, including the psoas major, the erector spinae, the quadratus lumborum, the musculus transversus abdominis, the obliquus externus abdominis and the obliquus internus abdominis. Skeletal muscle mass and height will be combined to report the third lumbar vertebrae skeletal muscle mass index(L3 SMI) in cm\^2/m\^2.
Time frame
baseline, 12 weeks post transplantation2
change of weight and height
Weight and height will be combined to report BMI in kg/m\^2.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks post transplantationSecondary outcomes
1
change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)
EQ-5D-5L is a 5-dimension questionnaire measuring health state and each dimension represents the level from 1 to 5, with higher level indicating worse health state.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks post transplantation2
change of the Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-rated questionnaire which assesses sleep quality over a 1-month time interval. Nineteen items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for seven components yields one global score, with higher score indicating worse sleep quality.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks post transplantation3
change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
FACIT-Fatigue is a 13-item test measuring fatigue and each item receives a value from 0 to 4, with higher value indicating worse fatigue state.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks post transplantation4
change of the Gastrointestinal Symptom Rating Scale(GSRS)
GSRS is a 13-item test to make a comprehensive assessment of common gastrointestinal symptom and each item receives a value from 0 to 3, with higher value indicating worse gastrointestinal condition.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks post transplantationSponsors and contacts
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Source ClinicalTrials.gov