Washed Microbiota Transplantation for Diabetic Gastroparesis

Not Applicable

Recruiting

• Conditions: Diabetic Gastroparesis
• Interventions: Other: washed microbiota transplantation; Other: placebo

• Registration Number: NCT06340217
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study Start: 2024-04-01
• Study First Posted: 2024-04-01
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2029-01
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

1. Diagnosed with diabetes for over 1 year;
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

Subjects meeting any of the following exclusion criteria must be excluded from the study:

Subjects who:

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	washed microbiota transplantation	The patient will receive WMT once daily for a duration of 2 days
Control	placebo	The patient will receive a placebo of equal volume once daily for a duration of 2 days

Primary Outcome Measures

Name	Time	Method
The proportion of DGP with symptom relief after the procedure.	Four-week post-WMT	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).

Secondary Outcome Measures

Name	Time	Method
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	GCS-DD consists of 13 items for evaluating the core symptom for past 24 hours.
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 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.
The incidence rate of adverse events;	One-week, Two-week, Four-week and Eight-week post-WMT	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.
The extent of change observed in gastrointestinal ultrasound (GIUS) of participants;	One-week, Two-week, Four-week and Eight-week post-WMT	The half gastric emptying time will be evaluated by GIUS.
The changes in gut microbiota composition and metabolites before and after treatment.	One-week, Two-week, Four-week and Eight-week post-WMT	The 16s-RNA or meta-analysis of gut microbiota will be used.
The extent of change observed in GCSI of participants;	One-week, Two-week and Eight-week post-WMT	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.
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	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.
The extent of change observed in electrogastrogram (EGG) of participants;	One-week, Two-week, Four-week and Eight-week post-WMT	The amplitude of gastric electric waves will be evaluated by EGG.

Trial Locations

Locations (1)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China