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NCT Number: NCT06447220

Washed Microbiota Transplantation for Malnutrition

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Expected survival time <3 months;
  • Women who are pregnant or breastfeeding;
  • Other patients deemed not suitable for enrollment by the investigator.

Treatment and study plan

washed microbiota transplantation

Procedure

The prepared microbiota suspension was infused into the patients' gut.

Other names: fecal microbiota transplantation

Primary outcomes

  1. change of the third lumbar vertebrae skeletal muscle mass and height

    Time frame: 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.

  2. change of weight and height

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

    Weight and height will be combined to report BMI in kg/m^2.

Secondary outcomes

  1. change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)

    Time frame: 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.

  2. change of the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  3. change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    Time frame: 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.

  4. change of the Gastrointestinal Symptom Rating Scale(GSRS)

    Time frame: 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.

  5. change of insulin-like growth factor I(IGF-I)

    Time frame: baseline, 12 weeks post transplantation

    Blood is tested for Insulin-like growth factor I.

  6. the difference of the gut microbiota composition before and after washed microbiota transplantation

    Time frame: 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.

  7. the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0

    Time frame: 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.).

Study contacts

Contact information is provided by the study sponsor or research team.

Bota Cui, PhD

CONTACT

[email protected]

086-025-58509884

Faming Zhang, PhD

CONTACT

[email protected]

086-025-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Jun 7, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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