Constipation
Conditions
Keywords
washed microbiota transplantation, constipation, difficult defecation
Brief summary
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.
Detailed description
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.
Interventions
DRUGHigh-dose washed microbiota suspension
The high-dose group will be administered a high dose of washed microbiota suspension。
DRUGLow-dose washed microbiota suspension
The low-dose group will be administered a low dose of washed microbiota suspension.
DRUGPlacebo
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.
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 70 Years
Healthy volunteers
No
Inclusion criteria
\- Meet all of the following inclusion criteria : 1. Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female. 2. For subjects diagnosed with chronic constipation, the duration of the disease is at least 6 months, and the following conditions are met: 1. Frequency of spontaneous defecation \<3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or manual assistance). 2. Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait Scale. 3. The subject or his/her legal representative has given informed consent, is fully aware of the purpose of the study, is able to communicate well with the investigator, and is able to understand and comply with the requirements of the study.
Exclusion criteria
\- All
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | Two-week post-WMT | 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.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | Day 5，Four-week post-WMT，Eight-week post-WMT | 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.). |
| The clinical response rate after treatment | One-week post-WMT，two-week post-WMT，Four-week post-WMT，Eight-week post-WMT | 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. |
| The weekly usage rate of assisted defecation drugs. | One-week post-WMT，Two-week post-WMT, Four-week post-WMT，Eight-week post-WMT | Percentage of days per week after WMT that assisted defecation drugs were used, which was compared to baseline. |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui
Outcome results
None listed