Washed Microbiota Transplantation Combined with Enteral Nutrition for Gastroptosis

NCT ID: NCT06837194

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-07-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Locations

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

Nanjing, Jangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, PhD

Role: CONTACT

fzhang@njmu.edu.cn

086-025-58509883

Bota Cui, PhD

Role: CONTACT

cuibota@njmu.edu.cn

086-025-58509884

Facility Contacts

Faming Zhang, PhD

Role: primary

fzhang@njmu.edu.cn

086-025-58509883

References

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.

Reference Type: BACKGROUND

PMID: 29691757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27556065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26526081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34746161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32289543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37804872 (View on PubMed)

Other Identifiers

WMT-gastroptosis

Identifier Type: -

Identifier Source: org_study_id