Clinical trial NCT06447220: Washed Microbiota Transplantation for Malnutrition
Official title: Washed Microbiota Transplantation for Malnutrition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Keywords: washed microbiota transplantation
malnutrition
fecal microbiota transplantation
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malnutrition receiving WMT will be enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of the third lumbar vertebrae skeletal muscle mass and height
timeFrame: baseline, 12 weeks post transplantation
measure: change of weight and height
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
Secondary outcomes:
measure: change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: change of the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: change of the Gastrointestinal Symptom Rating Scale(GSRS)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: change of insulin-like growth factor I(IGF-I)
timeFrame: baseline, 12 weeks post transplantation
measure: the difference of the gut microbiota composition before and after washed microbiota transplantation
timeFrame: baseline, 12 weeks post transplantation
measure: the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
timeFrame: 12 weeks post transplantation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.