Washed Microbiota Transplantation for Malnutrition

Malnutrition Clinical Trial

Official title:

Washed Microbiota Transplantation for Malnutrition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06447220
• Other study ID #: WMT-MN-2024
• Status: Recruiting
• Start date: June 2024
• Est. completion date: April 2031

Study information

• Verified date: June 2024
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, PhD
• Phone: 086-025-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years old;

2. Meet any of the following two conditions: ?weight loss (>5% weight loss in the past 6 months or >10% weight loss in more than 6 months); ?low 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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
China	Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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