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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Functional constipation is a common gastrointestinal condition affecting about 15% of people worldwide, significantly impacting daily life and quality of life. This research aims to evaluate the safety and effectiveness of combining fecal microbiota transplantation (FMT) with a prebiotic nutritional intervention in treating this condition. The study also seeks to understand changes in gut bacteria and metabolic profiles after treatment. Participants in the study receive FMT through colonoscopy, where beneficial bacteria from a healthy donor are transplanted into the digestive system to restore balance. This is combined with taking a high dietary fiber preparation dissolved in water shortly after the transplantation. Samples of blood, stool, and colon tissue are collected before and after treatment to monitor effects, and follow-up visits are conducted to assess progress. During the trial, researchers will track bowel movement frequency, stool consistency using the Bristol Stool Form Scale, and the severity of straining during defecation at multiple time points up to 24 weeks. They will also monitor any treatment-related side effects and analyze changes in gut microbiota composition through genetic sequencing. The study runs from baseline through follow-ups at weeks 2, 4, 8, 12, 18, and 24, with comprehensive participant evaluations throughout.
CONDITIONS
Brief 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
- Symptoms include at least two of the following in 25% or more of bowel movements: straining, hard stools (Bristol Stool Form Scale 1-2), incomplete evacuation, rectal obstruction sensation, need for finger assistance, or less than 3 spontaneous bowel movements per week
- Rarely have loose stools without laxatives
- Symptoms have lasted at least 6 months and meet criteria within the last 3 months
- Traditional treatments such as dietary changes, at least two laxatives, or probiotics have been ineffective
You will not qualify if you...
- Pregnant or breastfeeding
- Unable to take the intervention or complete required examinations
- Language expression disorders or mental illness
- Severe liver or kidney dysfunction
- Acute gastrointestinal disease within the past 4 weeks
- Constipation caused by surgery within the past 4 weeks
- History or abnormal exams indicating cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, blood disorders, or organic bowel disease
- Participation in another clinical trial within the past 3 months
- Other health problems that make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants undergo fecal microbiota transplantation (FMT) combined with a nutritional intervention involving high dietary fiber preparation. Colonoscopy and colostomy placement are performed, followed by bacterial infusion for 3 days and dietary fiber intake.
1 colonoscopy procedure and 3 daily visits for bacterial infusion
Duration - 24 weeks
Participants are followed for 24 weeks to monitor bowel movement frequency, stool consistency, defecation straining severity, gut microbiota changes, and treatment safety.
Visits at Weeks 2, 4, 8, 12, 18, and 24 for assessments
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
P
Pengguang Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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