Clinical trial NCT06837194: Washed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis
Official title: The Efficacy of WMT Combined with Nutritional Support in the Treatment of Malnutrition Complicated by Gastroptosis: a Real-World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroptosis
Malnutrition
Keywords: washed microbiota transplantation
microbiota medicine
Gastroptosis
malnutrition
enteral nutrition
Transendoscopic Enteral Tubing
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥18 years old with malnutrition and gastroptosis

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


Eligibility criteria: Inclusion Criteria:

* Subjects must meet all of the following inclusion criteria to enter the study:

  1. Clinically diagnosed with gastroptosis;
  2. 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);
  3. Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years;
  4. 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.

Exclusion Criteria:

* Subjects meeting any of the following exclusion criteria must be excluded from the study:

  1. Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning;
  2. Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition;
  3. Anticipated survival time \<3 months;
  4. 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;
  5. Poor pulmonary function deemed by investigators to impact study treatment (e.g., acute exacerbation of COPD or requirement for long-term oral/intravenous corticosteroids \[excluding inhaled corticosteroids\]);
  6. Active severe clinical infections (\> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections;
  7. Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement;
  8. Use of medications affecting or modulating gut microbiota within the past 48 hours;
  9. Lack of legal capacity or restricted legal capacity;
  10. Hematologic disorders unsuitable for blood draw examinations;
  11. Other severe medical conditions deemed by investigators to preclude patient enrollment.

Primary outcomes:
measure: The proportion of gastroptosis with degree relief after the procedure.
timeFrame: baseline, 12 weeks post transplantation
Secondary 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
measure: change of the Gastrointestinal Symptom Rating Scale(GSRS)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: The results of gastric fitted emptying rate data for 2 hours or 4 hours in the gastric emptying experiment with nuclide imaging
timeFrame: baseline, 12 weeks post transplantation
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: The extent of change observed in gastrointestinal ultrasound (GIUS) of participants
timeFrame: baseline, 12 weeks post transplantation
measure: The extent of change observed in transcranial Doppler (TCD) of participants
timeFrame: baseline, 12 weeks post transplantation
measure: change of the Hamilton Anxiety Scale(HAMA)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation
measure: change of the Hamilton Depression Scale(HAMD）
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: change of albumin and Prealbumin
timeFrame: baseline, 12 weeks post transplantation
measure: change of cytokine
timeFrame: baseline, 12 weeks post transplantation
measure: The changes in gut microbiota composition and metabolites before and after treatment
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: Jangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.