The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMT.
- Who it may be relevant to
- Registry conditions: Constipation - Functional, Fecal Microbiota Transplantation (FMT), Chronic Constipation. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure FMT
In this group, colonoscopy is performed and a colostomy is placed in the ileocecal region. Bacterial infusion is performed for 3 days with 100ml graft per day. Within 30 minutes after receiving the microbiota transplantation, take the high dietary fiber preparation and dissolve it in water according to the instructions. Blood, stool, and colonoscopy-derived mucosal samples are collected before and after FMT and Researchers conduct follow-ups.
Primary outcome measures
- Frequency of Defecation (Spontaneous Bowel Movements) [Time frame: Baseline, Weeks 4, 8, 12, 18, and 24]
- Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) [Time frame: Baseline, Weeks 4, 8, 12, 18, and 24]
- Severity of Defecation Straining [Time frame: Baseline, Weeks 4, 8, 12, 18, and 24]
Secondary outcome measures (2)
- Incidence of Treatment-Emergent Adverse Events [Time frame: From baseline through Week 24]
- Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing [Time frame: Baseline, Weeks 2, 4, 8, 12, 18, and 24]
Eligibility criteria
Inclusion criteria
- Age: 18 to 70.
- Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
- Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation; d. Rectal obstruction sensation; e. Need for finger assistance during defecation; f. Spontaneous bowel movements <3 times per week.
- It is rare to have loose stools without laxatives.
- Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.
- Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.
- Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
Exclusion criteria
- Pregnancy or lactation.
- Unable to take the intervention product or complete the examination as required.
- Language expression disorder or mental illness.
- Physical examination showed severe liver and kidney dysfunction.
- Acute gastrointestinal disease within 4 weeks.
- Constipation caused by surgery in the past 4 weeks.
- History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system diseases, organic bowel disease suggested by colonoscopy or imaging.
- Participation in other clinical trials within 3 months prior to enrollment.
- Other health problems are not suitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07387952 · I-25PJ1600