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Diabetic GastroparesisNCT06340217

Washed Microbiota Transplantation for Diabetic Gastroparesis

A study testing washed microbiota transplantation in people with Diabetic Gastroparesis, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Diabetic Gastroparesis
What is being tested?
washed microbiota transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteChina
Study dates
1 Apr 2024to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to enter the study:
  • 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.

Who cannot join

  • Subjects meeting any of the following exclusion criteria must be excluded from the study:
  • 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;
Show all 21Show fewer
  • 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);
  • Kidney disease with KDIGO stage 3b (GFR<45 ml/min/1.73m2) or above;
  • Have infectious diseases such as active hepatitis (requiring long-term use of drugs), HIV or active tuberculosis;
  • 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;
  • Other significant systemic illnesses, such as malignant tumors;
  • Have other situations in which the investigator deems it inappropriate to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Faming Zhang, PhD contact

086-025-58509883

fzhang@njmu.edu.cn

Bota Cui contact

086-025-58509884

cuibota@njmu.edu.cn

China1 site, 1 recruiting

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

    Nanjing, Jiangsu

    Faming Zhang, PhD, 086-025-58509883, fzhang@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of WMT in the Treatment of Diabetic Gastroparesis: A Multicenter, Randomized, Double-blind, Placebo-controlled Study

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

Read the detailed description

At least 44 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, Gastroparesis Cardinal Symptom Index (GCSI), Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM), Gastroparesis Core Symptom Daily Diary (GCS-DD), Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL), and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.

Being tested
washed microbiota transplantation, placebo
Keywords
washed microbiota transplantation, diabetic gastroparesis, randomized controlled trial, transendoscopic enteral tube, microbiota medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • washed microbiota transplantationOther

    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.

  • placeboOther

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

Study groups in NCT06340217
Study groupRoleWhat they receive
TreatmentExperimentalThe patient will receive WMT once daily for a duration of 2 days
Receives: Other: washed microbiota transplantation
ControlPlacebo comparatorThe patient will receive a placebo of equal volume once daily for a duration of 2 days
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate of DGP after WMT

    The response rate for each study group is defined as the number of responders divided by the total number of participants enrolled in that study group.

    A responder is defined as a participant who achieves at least a 50% decrease in the total Gastroparesis Cardinal Symptom Index (GCSI) score at Week 4 after WMT.

    A non-responder is defined as a participant who does not achieve at least a 50% decrease in the total GCSI score at Week 4, or who withdraws from the study early or switches to another treatment for any reason before the Week 4 assessment.

    Measured: Four-week post-WMT

Secondary outcomes (9)

  1. The extent of change observed in GCSI of participants;

    The GCSI consists of nine items and three subscales to measure symptoms related to gastroparesis. The nausea/vomiting subscale consists of the following three items: nausea, retching, and vomiting. The postprandial fullness/early satiety subscale consists of the following four items: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite.

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

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

    GCS-DD consists of 13 items for evaluating the core symptom for past 24 hours.

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

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

    Questionnaire was developed to measure specific symptoms of patients with upper gastrointestinal disorders. It records 20 symptoms (6 subscales) and assesses their severity within the 2 weeks prior to the test. Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe). The PAGI-SYM subscale scores have good internal consistency and test-retest reliability.

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

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

    The PAGI-QoL contains 30 items with five subscales:

    (1) daily activities (1-10); (2) clothing (11-12); (3) diet/food habits (13-19); (4) relationship (20-22); (5) psychological well-being and distress (23-30). Subscale scores are calculated by averaging the item responses.

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

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

    The frequency of gastric electric waves will be evaluated by EGG.

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

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

    The amplitude of gastric electric waves will be evaluated by EGG.

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

  7. The extent of change observed in gastrointestinal ultrasound (GIUS) of participants;

    The half gastric emptying time will be evaluated by GIUS.

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

  8. The incidence rate of adverse events;

    The number of adverse reactions reported by subjects in the WMT group from the start of treatment to the end of follow-up, divided by the total number of WMT treatments.

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

  9. The changes in gut microbiota composition and metabolites before and after treatment.

    The 16s-RNA or meta-analysis of gut microbiota will be used.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completionJan 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06340217
Sponsor's protocol ID
WMT-GDP-RCT
Status last verified
Aug 2026
First submitted
25 Mar 2024
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 23881199

  • 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.

    PubMed 32493829

  • Aswath GS, Foris LA, Ashwath AK, Patel K. Diabetic Gastroparesis(Archived). 2023 Mar 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430794/

    PubMed 28613545

  • 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.

    PubMed 36817869

  • 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.

    PubMed 35926490

  • 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.

    PubMed 33741641

  • 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.

    PubMed 32575130

  • 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.

    PubMed 35470243

  • 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.

    PubMed 32450364

  • 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.

    PubMed 36103991

  • 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.

    PubMed 37846600

  • 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.

    PubMed 33785557

  • 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.

    PubMed 37451270

  • 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.

    PubMed 30385743

  • 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.

    PubMed 37686774

Questions about this trial

What is this clinical trial studying?

A study testing washed microbiota transplantation in people with Diabetic Gastroparesis, run by The Second Hospital of Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of DGP after WMT (time frame: Four-week post-WMT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06340217, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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