Washed Microbiota Transplantation for Diabetic Gastroparesis

NCT06340217 | Recruiting DMC

• 1 other identifier: WMT-GDP-RCT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.

Conditions

Diabetic Gastroparesis

Keywords

washed microbiota transplantation; diabetic gastroparesis; randomized controlled trial; transendoscopic enteral tube; microbiota medicine

Outcome Measures

Primary Outcomes (1)

• The proportion of DGP with symptom relief after the procedure.

  Detailed evaluation content of efficacy rate of symptom: Symptom relief is defined as a decrease of at least 50% in the total Gastroparesis Cardinal Symptom Index (GCSI).

  Four-week post-WMT

Secondary Outcomes (9)

• The extent of change observed in GCSI of participants;

  One-week, Two-week and Eight-week post-WMT

• The extent of change observed in Gastroparesis Core Symptom Daily Diary (GCS-DD) of participants;

  One-week, Two-week, Four-week and Eight-week post-WMT

• The extent of change observed in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) of participants;

  One-week, Two-week, Four-week and Eight-week post-WMT

• The extent of change observed in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) of participants;

  One-week, Two-week, Four-week and Eight-week post-WMT

• The extent of change observed in electrogastrogram (EGG) of participants;

  One-week, Two-week, Four-week and Eight-week post-WMT

Study Arms (2)

Treatment

EXPERIMENTAL

The patient will receive WMT once daily for a duration of 2 days

Other: washed microbiota transplantation

Control

PLACEBO COMPARATOR

The patient will receive a placebo of equal volume once daily for a duration of 2 days

Other: placebo

Interventions

washed microbiota transplantation OTHER

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.

Treatment

placebo OTHER

A carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.

Control

Eligibility Criteria

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

You may qualify if:

• Diagnosed with diabetes for over 1 year;
• 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;
• Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;
• Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
• Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;
• 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.

You may not qualify if:

• Subjects who:
• Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
• 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;
• Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
• Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
• Have contraindications for intestinal tubing;
• Have a history of medication that regulate intestinal microbiome in last 48 hours;
• Have serious diabetic complications need immediately be dealt, such as diabetic ketoacidosis
• Have poor lung function and those deemed by the investigator to be affected by the study treatment, such as during COPD exacerbations;
• 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).
• 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);

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, Jiangsu, China

RECRUITING

Related Publications (21)

• Shin AS, Camilleri M. Diagnostic assessment of diabetic gastroparesis. Diabetes. 2013 Aug;62(8):2667-73. doi: 10.2337/db12-1706. No abstract available.

  PMID: 23881199 BACKGROUND

• 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.

  PMID: 32493829 BACKGROUND

• 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/

  PMID: 28613545 BACKGROUND

• 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.

  PMID: 36817869 BACKGROUND

• 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.

  PMID: 35926490 BACKGROUND

• 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.

  PMID: 33741641 BACKGROUND

• 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.

  PMID: 32575130 BACKGROUND

• 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.

  PMID: 35470243 BACKGROUND

• 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.

  PMID: 32450364 BACKGROUND

• 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.

  PMID: 36103991 BACKGROUND

• 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.

  PMID: 37846600 BACKGROUND

• 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.

  PMID: 33785557 BACKGROUND

• 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.

  PMID: 37451270 BACKGROUND

• 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.

  PMID: 30385743 BACKGROUND

• 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.

  PMID: 37686774 BACKGROUND

• 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.

  PMID: 36171079 BACKGROUND

• 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.

  PMID: 27126039 BACKGROUND

• 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.

  PMID: 33722860 BACKGROUND

• 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.

  PMID: 29311617 BACKGROUND

• 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.

  PMID: 28507013 BACKGROUND

• 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.

  PMID: 26374571 BACKGROUND

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)