Washed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis

NCT06837194 | Recruiting DMC

• 1 other identifier: WMT-gastroptosis
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroptosis; Malnutrition

Keywords

washed microbiota transplantation; microbiota medicine; Gastroptosis; malnutrition; enteral nutrition; Transendoscopic Enteral Tubing

Outcome Measures

Primary Outcomes (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.

  baseline, 12 weeks post transplantation

Secondary Outcomes (17)

• change of the third lumbar vertebrae skeletal muscle mass and height

  baseline, 12 weeks post transplantation

• change of weight and height

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

• change of the Gastrointestinal Symptom Rating Scale(GSRS)

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

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

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

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

  baseline, 12 weeks post transplantation

Study Arms (1)

Observation Group

Washed 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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 years old with malnutrition and gastroptosis

You may qualify if:

• 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.

You may not qualify if:

• 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 \[excluding inhaled corticosteroids\]);
• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jangsu, 210000, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 29691757 BACKGROUND

• 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.

  PMID: 27556065 BACKGROUND

• 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.

  PMID: 26526081 BACKGROUND

• 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.

  PMID: 34746161 BACKGROUND

• 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.

  PMID: 32289543 BACKGROUND

• 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.

  PMID: 37804872 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces, urine and blood

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Faming Zhang

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

Bota Cui, PhD

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)