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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT with nutritional intervention group | Experimental | Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota, by extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota. Nutritional intervention involves high dietary fiber preparation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Defecation (Spontaneous Bowel Movements) | The number of Spontaneous Bowel Movements (SBM) per week recorded by the participant in a diary. | Baseline, Weeks 4, 8, 12, 18, and 24 |
| 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. | Baseline, Weeks 4, 8, 12, 18, and 24 |
| 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. | Baseline, Weeks 4, 8, 12, 18, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline through Week 24 |
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Inclusion Criteria:
Age: 18 to 70.
Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:
Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengguang Yan | Contact | +8618810309887 | pengchengf@mail.sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jingnan Li, MD, Ph.D | Peking Union Medical College Hospital, Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| 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. | Baseline, Weeks 2, 4, 8, 12, 18, and 24 |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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