Actively Recruiting
Washed Microbiota Transplantation for Chronic Constipation in Adults
Led by The Second Hospital of Nanjing Medical University · Updated on 2023-10-30
18
Participants Needed
2
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Washed Microbiota Transplantation for Chronic Constipation in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent, aged 18 to 70 years, male or female
- Diagnosed with chronic constipation lasting at least 6 months
- Spontaneous bowel movements fewer than 3 times per week
- Stool is dry and hard, with more than a quarter being type 1 or 2 on the Bristol Stool Scale
- Able to understand and comply with study requirements and communicate with the investigator
You will not qualify if you...
- Have outlet obstruction constipation such as rectal mucosal prolapse
- History of abdominal or pelvic surgery except cholecystectomy, caesarean section, appendectomy, or intestinal polyp treatment without complications
- Intestinal stenosis from organic lesions in the digestive tract diagnosed by colonoscopy in past 24 months
- Systemic diseases affecting the digestive tract including neurological, muscle, mental, metabolic endocrine disorders, or opioid-induced constipation
- Major surgery or severe trauma within 3 months without full recovery
- Contraindications for endoscopic intestinal catheterization via colon including severe stenosis, obstruction, deep ulcer, or high perforation risk
- Serious cardiac abnormalities including NYHA class III or above, recent myocardial infarction or unstable angina, prolonged QTc interval, or uncontrolled arrhythmias
- Poor lung function affecting study treatment
- Uncontrolled immune disease or long-term hormone use (except topical)
- Poorly controlled metabolic diseases with gastrointestinal complications
- Reproductive system diseases prone to abdominal pain
- Significant lab abnormalities impacting safety or study completion
- Active hepatitis requiring treatment, HIV, or active tuberculosis
- History of drug or alcohol abuse exceeding defined limits
- Known allergy to the study drug or its components
- Use of anti-infective drugs within 14 days prior to enrollment or need for such therapy at evaluation
- Use of drugs affecting gastrointestinal motility that cannot be stopped for the trial
- Use of hydrotherapy for bowel cleansing within 1 month prior to treatment
- Pregnant or breastfeeding women or refusal to use contraception for 3 months post-treatment
- Participation in other drug clinical trials within 3 months prior to enrollment
- Presence of malignant tumors
- Any other condition deemed inappropriate by the investigator to participate in the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The second affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Actively Recruiting
2
the Second Affiliated of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Actively Recruiting
Research Team
F
Faming Zhang, PhD
CONTACT
B
Bota Cui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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