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GastroptosisNCT06837194

Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis

An observational study of Gastroptosis and 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

This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Gastroptosis, Malnutrition
Type of treatment
Injection or infusion
How many people
24 participants
Where
1 siteChina
Study dates
1 Feb 2025to 1 Jul 2027
How long will I take part?
24 Years
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients ≥18 years old with malnutrition and gastroptosis

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to enter the study:
  • Clinically diagnosed with gastroptosis;
  • Meets the diagnostic criteria for malnutrition (fulfilling any one of the following two criteria):
  • Weight loss (weight loss >5% within the last 6 months or >10% over more than 6 months);
  • Low BMI (BMI <18.5 kg/m² for individuals <70 years old; BMI <20 kg/m² for individuals ≥70 years old);
  • Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years;
  • Willing to voluntarily sign a written informed consent form and agrees to follow medical advice for regular follow-up examinations and monitoring after the completion of treatment.

Who cannot join

  • Subjects meeting any of the following exclusion criteria must be excluded from the study:
  • Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning;
  • Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition;
  • Anticipated survival time <3 months;
  • Clinically significant cardiovascular diseases, including heart failure (NYHA Class III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, history of myocardial infarction, hemodynamic instability at enrollment, unstable vital signs, or anticipated risk events during treatment;
  • Poor pulmonary function deemed by investigators to impact study treatment (e.g., acute exacerbation of COPD or requirement for long-term oral/intravenous corticosteroids [excluding inhaled corticosteroids]);
Show all 12Show fewer
  • Active severe clinical infections (> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections;
  • Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement;
  • Use of medications affecting or modulating gut microbiota within the past 48 hours;
  • Lack of legal capacity or restricted legal capacity;
  • Hematologic disorders unsuitable for blood draw examinations;
  • Other severe medical conditions deemed by investigators to preclude patient enrollment.

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, Jangsu, 210000

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

    Recruiting

Other trials in China

About this study

Official title: The Efficacy of WMT Combined With Nutritional Support in the Treatment of Malnutrition Complicated by Gastroptosis: A Real-World Study

This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients

Keywords
washed microbiota transplantation, microbiota medicine, Gastroptosis, malnutrition, enteral nutrition, Transendoscopic Enteral Tubing
Medical subject headings
Malnutrition

What participants receive

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

Study groups in NCT06837194
Study groupRoleWhat they receive
Observation GroupWashed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive three doses of WMT and enteral nutrition for three months for gastroptosis.

What is being measured

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

  1. The proportion of gastroptosis with degree relief after the procedure.

    Detailed evaluation content of efficacy rate of degree: The ultrasound examination was divided into three levels of light, medium and heavy according to the specific value of the middle gastric angle below Iliac spines are connected, defined as a reduction of at least 50% in value or a reduction of degree.

    Measured: baseline, 12 weeks post transplantation

Secondary outcomes (17)

  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

  3. 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

  4. The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants

    The GCSI consists of nine items and three subscales to measure symptoms related to gastroparesis. The nausea/vomiting subscale consists of the following three items: nausea, retching, and vomiting. The postprandial fullness/early satiety subscale consists of the following four items: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite.

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

  5. The results of gastric fitted emptying rate data for 2 hours or 4 hours in the gastric emptying experiment with nuclide imaging

    Measured: baseline, 12 weeks post transplantation

  6. 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

  7. 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

  8. 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

  9. The extent of change observed in gastrointestinal ultrasound (GIUS) of participants

    The half gastric emptying time will be evaluated by GIUS.

    Measured: baseline, 12 weeks post transplantation

  10. The extent of change observed in transcranial Doppler (TCD) of participants

    TCD was used to evaluate the degree of continuity of echo in the nucleus suture in patients, and echoic discontinuity represented the possibility of anxiety and depression.

    Measured: baseline, 12 weeks post transplantation

  11. change of the Hamilton Anxiety Scale(HAMA)

    Hamilton Anxiety Scale is a 14-item test measuring anxiety and each item receives a value from 0 to 4, with higher value indicating worse anxiety state.

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

  12. change of the Hamilton Depression Scale(HAMD）

    Hamilton Depression Scale is a 17-item test measuring depression and each item receives a value from 0 to 4, with higher value indicating worse depression state.

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

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

    Blood is tested for Insulin-like growth factor I.

    Measured: baseline, 12 weeks post transplantation

  14. change of albumin and Prealbumin

    Blood is tested for albumin and Prealbumin.

    Measured: baseline, 12 weeks post transplantation

  15. change of cytokine

    Blood is tested for IL-1β、IL-2、IL-4、IL-5、IL-6、IL-8、IL-10、IL-12p70、IL-17、TNF-α、IFN-γ、IFN-α.

    Measured: baseline, 12 weeks post transplantation

  16. The changes in gut microbiota composition and metabolites before and after treatment

    The 16s-RNA or meta-analysis of gut microbiota will be used.

    Measured: baseline, 12 weeks post transplantation

  17. 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 posted20 Feb 2025
  2. Study start1 Feb 2025
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Jul 2027 (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
Prospective
Enrolment
24 participants (estimated)
Target duration
24 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06837194
Sponsor's protocol ID
WMT-gastroptosis
Status last verified
Feb 2025
First submitted
10 Feb 2025
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.

    PubMed 29691757

  • Quince C, Ijaz UZ, Loman N, Eren AM, Saulnier D, Russell J, Haig SJ, Calus ST, Quick J, Barclay A, Bertz M, Blaut M, Hansen R, McGrogan P, Russell RK, Edwards CA, Gerasimidis K. Extensive Modulation of the Fecal Metagenome in Children With Crohn's Disease During Exclusive Enteral Nutrition. Am J Gastroenterol. 2015 Dec;110(12):1718-29; quiz 1730. doi: 10.1038/ajg.2015.357. Epub 2015 Nov 3.

    PubMed 26526081

  • Fernandes ND, Murphy SA. Gastroptosis: An Uncommon Cause for a Deep Nasogastric Tube. Clin Gastroenterol Hepatol. 2021 Jun;19(6):A23. doi: 10.1016/j.cgh.2020.04.016. Epub 2020 Apr 11. No abstract available.

    PubMed 32289543

  • Xu LC, Garcia JC. Gastroptosis in a young woman. Gastrointest Endosc. 2024 Mar;99(3):454-455. doi: 10.1016/j.gie.2023.10.006. Epub 2023 Oct 5. No abstract available.

    PubMed 37804872

  • Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.

    PubMed 27556065

  • 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 Gastroptosis and 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 7 inclusion and 12 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 20 Feb 2025. 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?

The proportion of gastroptosis with degree relief after the procedure. (time frame: baseline, 12 weeks post transplantation). 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 NCT06837194, 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 20 Feb 2025.

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