Washed Microbiota Transplantation for Malnutrition
- Registration Number
- NCT06447220
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- Brief Summary
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.
- Detailed Description
The gut microbiota of malnourished patients is different from that of healthy people. The diversity of the gut microbiota of patients with severe malnutrition reduced and the abundance of Proteobacteria significantly increased, as well as pathogenic genera such as Klebsiella, Escherichia coli, Shigella, and Streptococcus. This suggests that gut microbiota plays an important role in the occurrence and development of malnutrition. Dietary intervention targeting gut microbiota can quickly improve children's malnutrition, promote weight gain and increase protein levels that promote bone growth and nerve development. Exclusive enteral nutrition combined with immediate washed microbiota transplantation(WMT) can rapidly improve the nutritional status of patients with Crohn's disease compared with those with delayed WMT. Gut microbiota has been confirmed to be closely related to malnutrition. Improving the disordered gut microbiota in malnourished patients may become a potential treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- Expected survival time <3 months;
- Women who are pregnant or breastfeeding;
- Other patients deemed not suitable for enrollment by the investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description The malnourished undergoing washed microbiota transplantation washed microbiota transplantation patients undergoing washed microbiota transplantation who were diagnosed as malnutrition according to weight loss or low BMI
- Primary Outcome Measures
Name Time Method change of weight and height baseline, 4 weeks, 8 weeks, 12 weeks post transplantation Weight and height will be combined to report BMI in kg/m\^2.
change of the third lumbar vertebrae skeletal muscle mass and height baseline, 12 weeks post transplantation 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.
- Secondary Outcome Measures
Name Time Method change of the Pittsburgh Sleep Quality Index (PSQI) baseline, 4 weeks, 8 weeks, 12 weeks post transplantation 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.
change of insulin-like growth factor I(IGF-I) baseline, 12 weeks post transplantation Blood is tested for Insulin-like growth factor I.
the difference of the gut microbiota composition before and after washed microbiota transplantation baseline, 12 weeks post transplantation The composition of the gut microbiota is evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism.
change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) baseline, 4 weeks, 8 weeks, 12 weeks post transplantation 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.
change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) baseline, 4 weeks, 8 weeks, 12 weeks post transplantation 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.
change of the Gastrointestinal Symptom Rating Scale(GSRS) baseline, 4 weeks, 8 weeks, 12 weeks post transplantation 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.
the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 12 weeks post transplantation The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Trial Locations
- Locations (1)
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China