Washed Microbiota Transplantation for Malnutrition

NCT06447220 | Recruiting DMC

• 1 other identifier: WMT-MN-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

washed microbiota transplantation; malnutrition; fecal microbiota transplantation

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, 12 weeks post transplantation

• change of weight and height

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

  baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

Secondary Outcomes (7)

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

  baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

• change of the Pittsburgh Sleep Quality Index (PSQI)

  baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

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

  baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

• change of the Gastrointestinal Symptom Rating Scale(GSRS)

  baseline, 4 weeks, 8 weeks, 12 weeks post transplantation

• change of insulin-like growth factor I(IGF-I)

  baseline, 12 weeks post transplantation

Study Arms (2)

The malnourished undergoing washed microbiota transplantation

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

Procedure: washed microbiota transplantation

The malnourished not undergoing washed microbiota transplantation

The malnourished patients did not undergo washed microbiota transplantation

Interventions

washed microbiota transplantation PROCEDURE

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

Also known as: fecal microbiota transplantation

The malnourished undergoing washed microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malnutrition receiving WMT will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

RECRUITING

Related Publications (6)

• Miller J, Wells L, Nwulu U, Currow D, Johnson MJ, Skipworth RJE. Validated screening tools for the assessment of cachexia, sarcopenia, and malnutrition: a systematic review. Am J Clin Nutr. 2018 Dec 1;108(6):1196-1208. doi: 10.1093/ajcn/nqy244.

  PMID: 30541096 BACKGROUND

• Dent E, Wright ORL, Woo J, Hoogendijk EO. Malnutrition in older adults. Lancet. 2023 Mar 18;401(10380):951-966. doi: 10.1016/S0140-6736(22)02612-5. Epub 2023 Jan 27.

  PMID: 36716756 BACKGROUND

• Fontaine F, Turjeman S, Callens K, Koren O. The intersection of undernutrition, microbiome, and child development in the first years of life. Nat Commun. 2023 Jun 15;14(1):3554. doi: 10.1038/s41467-023-39285-9.

  PMID: 37322020 BACKGROUND

• Coley EJL, Hsiao EY. Malnutrition and the microbiome as modifiers of early neurodevelopment. Trends Neurosci. 2021 Sep;44(9):753-764. doi: 10.1016/j.tins.2021.06.004. Epub 2021 Jul 21.

  PMID: 34303552 BACKGROUND

• Chen RY, Mostafa I, Hibberd MC, Das S, Mahfuz M, Naila NN, Islam MM, Huq S, Alam MA, Zaman MU, Raman AS, Webber D, Zhou C, Sundaresan V, Ahsan K, Meier MF, Barratt MJ, Ahmed T, Gordon JI. A Microbiota-Directed Food Intervention for Undernourished Children. N Engl J Med. 2021 Apr 22;384(16):1517-1528. doi: 10.1056/NEJMoa2023294. Epub 2021 Apr 7.

  PMID: 33826814 BACKGROUND

• Xiang L, Yu Y, Ding X, Zhang H, Wen Q, Cui B, Zhang F. Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation in Crohn's Disease With Malnutrition: A Randomized Pilot Study. Front Med (Lausanne). 2021 Oct 22;8:666062. doi: 10.3389/fmed.2021.666062. eCollection 2021.

  PMID: 34746161 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal, blood and urine samples before and 12 weeks after washed microbiota transplantation

MeSH Terms

Conditions

Malnutrition

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

Bota Cui, PhD

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 7, 2024
• Study Start: December 17, 2023
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: July 10, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)