This is a single-center, randomized, double-blind, placebo-controlled, dose-exploring clinical study to explore the safety and efficacy of washed microbiota transplantation (WMT) for patients with chronic constipation.
At least 18 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the high-dose group (high dose of washed microbiota suspension), the low-dose group (low dose of washed microbiota suspension) and the control group (placebo). Data of demographic characteristics, intestinal symptoms,medicine treatment usage and clinical outcomes will be collected. After treatment (D1-D4), they will enter the double-blind visit (D5, D18) for safety and efficacy evaluation. Open follow-up periods will be performed on days 32 and 60 after administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
The high-dose group will be administered a high dose of washed microbiota suspension。
The low-dose group will be administered a low dose of washed microbiota suspension.
The control group will be given equal volume placebo (120ml carrier solution matching the volume of WMT-001), which contains 10% sterile glycerol and saline injection. The drug was administered once a day for 4 days.
The second affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGthe Second Affiliated of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Time frame: Two-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Time frame: Day 5,Four-week post-WMT,Eight-week post-WMT
The clinical response rate after treatment
A clinical response was defined as a patient achieving complete spontaneous bowel movement (CSBM) at least 50% of the time after receiving WMT. CSBM was defined as the number of spontaneous defecation with complete exhaust feeling without taking remedial purgative or manual assistance.
Time frame: One-week post-WMT,two-week post-WMT,Four-week post-WMT,Eight-week post-WMT
The weekly usage rate of assisted defecation drugs.
Percentage of days per week after WMT that assisted defecation drugs were used, which was compared to baseline.
Time frame: One-week post-WMT,Two-week post-WMT, Four-week post-WMT,Eight-week post-WMT
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