Washed Microbiota Transplantation for Malnutrition

Overview

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

• Procedure washed microbiota transplantation
  The prepared microbiota suspension was infused into the patients' gut.

Primary outcome measures

• change of the third lumbar vertebrae skeletal muscle mass and height [Time frame: baseline, 12 weeks post transplantation]
• change of weight and height [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]

Secondary outcome measures (7)

• change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Gastrointestinal Symptom Rating Scale(GSRS) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of insulin-like growth factor I(IGF-I) [Time frame: baseline, 12 weeks post transplantation]
• the difference of the gut microbiota composition before and after washed microbiota transplantation [Time frame: baseline, 12 weeks post transplantation]
• the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 [Time frame: 12 weeks post transplantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affi — Nanjing

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06447220 · WMT-MN-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗