The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Frequency of Defecation (Spontaneous Bowel Movements)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FMT with nutritional intervention group
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.
干预措施: FMT (Procedure)
结局指标
主要结局
Frequency of Defecation (Spontaneous Bowel Movements)
时间窗: Baseline, Weeks 4, 8, 12, 18, and 24
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)
时间窗: Baseline, Weeks 4, 8, 12, 18, and 24
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
时间窗: Baseline, Weeks 4, 8, 12, 18, and 24
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.
次要结局
- Incidence of Treatment-Emergent Adverse Events(From baseline through Week 24)
- Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing(Baseline, Weeks 2, 4, 8, 12, 18, and 24)