Washed Microbiota Transplantation for Diabetic Gastroparesis
NCT ID: NCT06340217
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
46 participants
INTERVENTIONAL
2024-04-01
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
NCT06340828
A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
NCT03268941
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
NCT02025725
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
NCT02025751
Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
NCT00845858
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
The patient will receive WMT once daily for a duration of 2 days
washed microbiota transplantation
Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive two doses of WMT for DGP.
Control
The patient will receive a placebo of equal volume once daily for a duration of 2 days
placebo
A carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
washed microbiota transplantation
Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive two doses of WMT for DGP.
placebo
A carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to 2.3;
3. Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;
4. Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
5. Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;
6. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
Exclusion Criteria
1. Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
2. Have a prior history of gastric surgery, including but not limited to gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or vagotomy in past 1 year;
3. Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
4. Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
5. Have contraindications for intestinal tubing;
6. Have a history of medication that regulate intestinal microbiome in last 48 hours;
7. Have serious diabetic complications need immediately be dealt, such as diabetic ketoacidosis
8. Have poor lung function and those deemed by the investigator to be affected by the study treatment, such as during COPD exacerbations;
9. Have any of the following abnormalities in cardiac function and cardiac performance:
* Cardiac function rating≥Ⅲ according to New York Heart Association (NYHA);
* New myocardial infarction or unstable angina pectoris within 6 months;
* Electrocardiogram indicated prolonged QTc interval (male QTc≥450ms, female QTc≥470ms);
* requiring drug intervention (more than Ⅱ atrioventricular block).
10. Have preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points);
11. Kidney disease with KDIGO stage 3b (GFR\<45 ml/min/1.73m2) or above;
12. Have infectious diseases such as active hepatitis (requiring long-term use of drugs), HIV or active tuberculosis;
13. Have a history of drug abuse, alcoholism (defined as consuming more than 14 units per week, with 1 unit equivalent to 360 mL of beer, 45 mL of 40% alcohol, or 150 mL of wine), or substance misuse;
14. Other significant systemic illnesses, such as malignant tumors;
15. Have other situations in which the investigator deems it inappropriate to participate in this study.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Second Hospital of Nanjing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Faming Zhang
Professor, Gastroenterology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Faming Zhang
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Nanjing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Shin AS, Camilleri M. Diagnostic assessment of diabetic gastroparesis. Diabetes. 2013 Aug;62(8):2667-73. doi: 10.2337/db12-1706. No abstract available.
Ye Y, Jiang B, Manne S, Moses PL, Almansa C, Bennett D, Dolin P, Ford AC. Epidemiology and outcomes of gastroparesis, as documented in general practice records, in the United Kingdom. Gut. 2021 Apr;70(4):644-653. doi: 10.1136/gutjnl-2020-321277. Epub 2020 Jun 3.
Aswath GS, Foris LA, Ashwath AK, Patel K. Diabetic Gastroparesis. 2023 Mar 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430794/
Liu J, Liu M, Chai Z, Li C, Wang Y, Shen M, Zhuang G, Zhang L. Projected rapid growth in diabetes disease burden and economic burden in China: a spatio-temporal study from 2020 to 2030. Lancet Reg Health West Pac. 2023 Feb 3;33:100700. doi: 10.1016/j.lanwpc.2023.100700. eCollection 2023 Apr.
Camilleri M, Kuo B, Nguyen L, Vaughn VM, Petrey J, Greer K, Yadlapati R, Abell TL. ACG Clinical Guideline: Gastroparesis. Am J Gastroenterol. 2022 Aug 1;117(8):1197-1220. doi: 10.14309/ajg.0000000000001874. Epub 2022 Jun 3.
Vosoughi K, Ichkhanian Y, Benias P, Miller L, Aadam AA, Triggs JR, Law R, Hasler W, Bowers N, Chaves D, Ponte-Neto AM, Draganov P, Yang D, El Halabi M, Sanaei O, Brewer Gutierrez OI, Bulat RS, Pandolfino J, Khashab M. Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial. Gut. 2022 Jan;71(1):25-33. doi: 10.1136/gutjnl-2020-322756. Epub 2021 Mar 19.
Ragi O, Jacques J, Branche J, Leblanc S, Vanbiervliet G, Legros R, Pioche M, Rivory J, Chaussade S, Barret M, Wallenhorst T, Barthet M, Kerever S, Gonzalez JM. One-year results of gastric peroral endoscopic myotomy for refractory gastroparesis: a French multicenter study. Endoscopy. 2021 May;53(5):480-490. doi: 10.1055/a-1205-5686. Epub 2020 Jul 21.
Martinek J, Hustak R, Mares J, Vackova Z, Spicak J, Kieslichova E, Buncova M, Pohl D, Amin S, Tack J. Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. Gut. 2022 Nov;71(11):2170-2178. doi: 10.1136/gutjnl-2022-326904. Epub 2022 Apr 25.
Abdelfatah MM, Noll A, Kapil N, Shah R, Li L, Nustas R, Li B, Luo H, Chen H, Xia L, Mekaroonkamol P, Shahnavaz N, Keilin S, Willingham F, Christie J, Cai Q. Long-term Outcome of Gastric Per-Oral Endoscopic Pyloromyotomy in Treatment of Gastroparesis. Clin Gastroenterol Hepatol. 2021 Apr;19(4):816-824. doi: 10.1016/j.cgh.2020.05.039. Epub 2020 May 22.
Wang Y, Zhang S, Borody TJ, Zhang F. Encyclopedia of fecal microbiota transplantation: a review of effectiveness in the treatment of 85 diseases. Chin Med J (Engl). 2022 Aug 20;135(16):1927-1939. doi: 10.1097/CM9.0000000000002339.
Li Y, Liu Q, Zhang L, Zou J, He R, Zhou Y, Qian C, Zhu Y, Chen R, Zhang Y, Cai P, Wang M, Shao W, Ji M, Wu H, Zhang F, Liu Z, Liu Y. Washed microbiota transplantation reduces glycemic variability in unstable diabetes. J Diabetes. 2024 Feb;16(2):e13485. doi: 10.1111/1753-0407.13485. Epub 2023 Oct 17.
Ng SC, Xu Z, Mak JWY, Yang K, Liu Q, Zuo T, Tang W, Lau L, Lui RN, Wong SH, Tse YK, Li AYL, Cheung K, Ching JYL, Wong VWS, Kong APS, Ma RCW, Chow EYK, Wong SKH, Ho ICH, Chan PKS, Chan FKL. Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial. Gut. 2022 Apr;71(4):716-723. doi: 10.1136/gutjnl-2020-323617. Epub 2021 Mar 30.
Yang J, Yang X, Wu G, Huang F, Shi X, Wei W, Zhang Y, Zhang H, Cheng L, Yu L, Shang J, Lv Y, Wang X, Zhai R, Li P, Cui B, Fang Y, Deng X, Tang S, Wang L, Yuan Q, Zhao L, Zhang F, Zhang C, Yuan H. Gut microbiota modulate distal symmetric polyneuropathy in patients with diabetes. Cell Metab. 2023 Sep 5;35(9):1548-1562.e7. doi: 10.1016/j.cmet.2023.06.010. Epub 2023 Jul 13.
Camilleri M, Chedid V, Ford AC, Haruma K, Horowitz M, Jones KL, Low PA, Park SY, Parkman HP, Stanghellini V. Gastroparesis. Nat Rev Dis Primers. 2018 Nov 1;4(1):41. doi: 10.1038/s41572-018-0038-z.
Huang Y, Guo Y, Li X, Xiao Y, Wang Z, Song L, Ren Z. Effects of Lactiplantibacillus plantarum GUANKE on Diphenoxylate-Induced Slow Transit Constipation and Gut Microbiota in Mice. Nutrients. 2023 Aug 26;15(17):3741. doi: 10.3390/nu15173741.
Prochazkova N, Falony G, Dragsted LO, Licht TR, Raes J, Roager HM. Advancing human gut microbiota research by considering gut transit time. Gut. 2023 Jan;72(1):180-191. doi: 10.1136/gutjnl-2022-328166. Epub 2022 Sep 28.
Falony G, Joossens M, Vieira-Silva S, Wang J, Darzi Y, Faust K, Kurilshikov A, Bonder MJ, Valles-Colomer M, Vandeputte D, Tito RY, Chaffron S, Rymenans L, Verspecht C, De Sutter L, Lima-Mendez G, D'hoe K, Jonckheere K, Homola D, Garcia R, Tigchelaar EF, Eeckhaudt L, Fu J, Henckaerts L, Zhernakova A, Wijmenga C, Raes J. Population-level analysis of gut microbiome variation. Science. 2016 Apr 29;352(6285):560-4. doi: 10.1126/science.aad3503. Epub 2016 Apr 28.
Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.
Larraufie P, Martin-Gallausiaux C, Lapaque N, Dore J, Gribble FM, Reimann F, Blottiere HM. SCFAs strongly stimulate PYY production in human enteroendocrine cells. Sci Rep. 2018 Jan 8;8(1):74. doi: 10.1038/s41598-017-18259-0.
Dimidi E, Christodoulides S, Scott SM, Whelan K. Mechanisms of Action of Probiotics and the Gastrointestinal Microbiota on Gut Motility and Constipation. Adv Nutr. 2017 May 15;8(3):484-494. doi: 10.3945/an.116.014407. Print 2017 May.
Horvath VJ, Putz Z, Izbeki F, Korei AE, Gero L, Lengyel C, Kempler P, Varkonyi T. Diabetes-related dysfunction of the small intestine and the colon: focus on motility. Curr Diab Rep. 2015 Nov;15(11):94. doi: 10.1007/s11892-015-0672-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WMT-GDP-RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.