Diabetic Gastroparesis
Conditions
Keywords
washed microbiota transplantation, diabetic gastroparesis, randomized controlled trial, transendoscopic enteral tube, microbiota medicine
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.
Interventions
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.
OTHERplacebo
A carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of DGP after WMT | Four-week post-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 extent of change observed in electrogastrogram (EGG) of participants; | One-week, Two-week, Four-week and Eight-week post-WMT | The frequency of gastric electric waves will be evaluated by EGG. |
| 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 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 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. |
Countries
China
Contacts
CONTACTFaming Zhang, PhD
CONTACTBota Cui
PRINCIPAL_INVESTIGATORFaming Zhang
The Second Hospital of Nanjing Medical University
Outcome results
None listed