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

Overview

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

Primary outcome measures

• The proportion of gastroptosis with degree relief after the procedure. [Time frame: baseline, 12 weeks post transplantation]

Secondary outcome measures (12)

• change of the third lumbar vertebrae skeletal muscle mass and height [Time frame: baseline, 12 weeks post transplantation]
• change of weight and height [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Gastrointestinal Symptom Rating Scale(GSRS) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• The extent of change observed in Gastroparesis Cardinal Symptom Index(GCSI)of participants [Time frame: 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 [Time frame: baseline, 12 weeks post transplantation]
• change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• The extent of change observed in gastrointestinal ultrasound (GIUS) of participants [Time frame: baseline, 12 weeks post transplantation]
• The extent of change observed in transcranial Doppler (TCD) of participants [Time frame: baseline, 12 weeks post transplantation]
• change of the Hamilton Anxiety Scale(HAMA) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]
• change of the Hamilton Depression Scale(HAMD） [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks post transplantation]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affi — Nanjing

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34746161

Identifiers

NCT: NCT06837194 · WMT-gastroptosis

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗