Malnutrition
Conditions
Keywords
washed microbiota transplantation, malnutrition, fecal microbiota transplantation
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.
Interventions
PROCEDUREwashed microbiota transplantation
The prepared microbiota suspension was infused into the patients' gut.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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.). |
| change of insulin-like growth factor I(IGF-I) | baseline, 12 weeks post transplantation | Blood is tested for Insulin-like growth factor I. |
| 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. |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui, PhD
Outcome results
None listed