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.
Age: 18 to 70.
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.
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.
Single group
FMT
Procedure/SurgeryIn 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.
Frequency of Defecation (Spontaneous Bowel Movements)
The number of Spontaneous Bowel Movements (SBM) per week recorded by the participant in a diary.
Stool Consistency Assessed by Bristol Stool Form Scale (BSFS)
Stool consistency is evaluated using the Bristol Stool Form Scale. The scale ranges from Type 1 (Separate hard lumps) to Type 7 (Liquid consistency). Type 1 and 2 indicate constipation, while Type 3 and 4 are considered normal. Higher scores indicate looser stool consistency.
Severity of Defecation Straining
Patient-reported assessment of the effort required to defecate. Participants rate their straining severity on a scale (e.g., from 0 to 3, where 0 represents no straining and 3 represents severe straining). Higher scores indicate worse symptoms.
Incidence of Treatment-Emergent Adverse Events
Number of participants with adverse events. Assessment includes monitoring for specific gastrointestinal symptoms (e.g., aggravation of diarrhea, abdominal discomfort/bloating) and systemic infections (e.g., secondary intestinal infection, bacteremia). Safety is assessed via telephone and offline visits.
Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing
Fecal samples are collected to analyze the changes in the gut microbiota structure. Analysis includes the relative abundance of bacterial species and diversity indices (e.g., Shannon index) using Metastats analysis to compare pre- and post-treatment compositions.
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