Actively Recruiting
The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
Led by Peking Union Medical College Hospital · Updated on 2026-02-04
5
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.
CONDITIONS
Official Title
The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosed with functional constipation according to Rome IV criteria
- At least 2 of the following symptoms in 25% or more of bowel movements: straining, hard stool (Bristol Stool score 1-2), incomplete evacuation, rectal obstruction sensation, need for finger assistance, or fewer than 3 spontaneous bowel movements per week
- Rare occurrence of loose stools without laxatives
- Exclusion of irritable bowel syndrome diagnosis
- Symptoms present for at least 6 months and meeting criteria within the last 3 months
- Ineffective traditional treatments including dietary intervention and at least two laxatives or probiotics
You will not qualify if you...
- Pregnancy or breastfeeding
- Unable to take the intervention product or complete required examinations
- Language difficulties or mental illness
- Severe liver or kidney dysfunction based on physical exam
- Acute gastrointestinal disease within the last 4 weeks
- Constipation caused by surgery in the past 4 weeks
- History or abnormal findings of cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, stroke, heart disease, cirrhosis, renal failure, blood system diseases, or organic bowel disease
- Participation in other clinical trials within 3 months prior to enrollment
- Other health problems that make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
P
Pengguang Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here