Washed Microbiota Transplantation for Malnutrition

Nanjing Medical University

Status: Enrolling

Conditions: Malnutrition

Treatments: Procedure: washed microbiota transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT06447220

WMT-MN-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

The malnourished undergoing washed microbiota transplantation

Description:

patients undergoing washed microbiota transplantation who were diagnosed as malnutrition according to weight loss or low BMI

Treatment:

Procedure: washed microbiota transplantation

The malnourished not undergoing washed microbiota transplantation

Description:

The malnourished patients did not undergo washed microbiota transplantation