AzTrials
AzTrials

MalnutritionNCT06447220

Washed Microbiota Transplantation for Malnutrition

An observational study of Malnutrition, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malnutrition
What is being tested?
washed microbiota transplantation
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteChina
Study dates
17 Dec 2023to Apr 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with malnutrition receiving WMT will be enrolled.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Faming Zhang, PhD contact

086-025-58509883

fzhang@njmu.edu.cn

Bota Cui, PhD contact

086-025-58509884

cuibota@njmu.edu.cn

China1 site, 1 recruiting

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

    Nanjing, Jiangsu

    Faming Zhang, PhD, 086-025-58509883, fzhang@njmu.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions
Malnutrition
Being tested
washed microbiota transplantation
Keywords
washed microbiota transplantation, malnutrition, fecal microbiota transplantation
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • washed microbiota transplantationProcedure or surgery

    Also called fecal microbiota transplantation

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

Study groups in NCT06447220
Study groupRoleWhat they receive
The malnourished undergoing washed microbiota transplantationpatients undergoing washed microbiota transplantation who were diagnosed as malnutrition according to weight loss or low BMI
Receives: Procedure: washed microbiota transplantation
The malnourished not undergoing washed microbiota transplantationThe malnourished patients did not undergo washed microbiota transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 12 weeks post transplantation

  2. change of weight and height

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

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

Secondary outcomes (7)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

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

    Blood is tested for Insulin-like growth factor I.

    Measured: baseline, 12 weeks post transplantation

  6. 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.

    Measured: baseline, 12 weeks post transplantation

  7. 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.).

    Measured: 12 weeks post transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start17 Dec 2023
  3. Primary completionDec 2030 (estimated)
  4. Study completionApr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06447220
Sponsor's protocol ID
WMT-MN-2024
Status last verified
Oct 2026
First submitted
19 May 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 34746161

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition, run by The Second Hospital of Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of the third lumbar vertebrae skeletal muscle mass and height (time frame: baseline, 12 weeks post transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06447220, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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