Trial Comparing the Efficacy of Transanal Irrigation Versus Standard Bowel Care in Patients With Parkinson's Disease and Severe Constipation. Impact on Gut Microbiome and Motor Disorders. TAI-PD Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
研究概览
简要总结
Constipation is one of the most common and disabling non-motor symptoms of Parkinson's disease (PD), often resulting in reduced quality of life and increased healthcare burden. Standard bowel care (SBC), including dietary modifications, fluid intake, physical activity, and laxative therapy, may not provide adequate symptom control in patients with severe constipation.
The purpose of this study is to evaluate whether transanal irrigation (TAI) using the Qufora Flow device is more effective than SBC in improving bowel function in patients with PD and severe constipation. In addition to bowel symptom improvement, the study will investigate the potential effects of TAI on gut microbiota composition, motor and non-motor symptoms of PD, treatment adherence, and safety.
Participants will be randomly assigned to receive either TAI or SBC and will be followed for 24 months. Clinical assessments, patient-reported outcome measures, and stool samples will be collected throughout the study to evaluate treatment effectiveness and to explore the relationship between bowel management, gut microbiota, and Parkinson's disease progression.
详细描述
Constipation affects up to 80% of individuals with Parkinson's disease (PD) and frequently precedes the onset of motor symptoms. It represents one of the most burdensome non-motor manifestations of the disease, significantly impairing quality of life and increasing the need for healthcare interventions. Despite the widespread use of standard bowel care (SBC), many patients continue to experience persistent constipation, highlighting the need for more effective therapeutic strategies.
Transanal irrigation (TAI) is an established bowel management technique that has demonstrated efficacy in patients with neurogenic bowel dysfunction resulting from spinal cord injury, multiple sclerosis, and other neurological disorders. However, evidence regarding its effectiveness in patients with Parkinson's disease remains limited.
This multicenter, randomized controlled trial has been designed to compare the effectiveness of TAI using the Qufora Flow device with SBC in adults with Parkinson's disease and severe constipation. The study will evaluate whether TAI provides superior long-term bowel symptom control while also investigating its impact on patient-reported outcomes, treatment adherence, and safety.
An additional objective of the study is to explore the relationship between bowel management and gut microbiota composition. Increasing evidence suggests that alterations in the gut microbiome may contribute to the pathophysiology and progression of Parkinson's disease through the gut-brain axis. By analyzing longitudinal stool samples, the study aims to determine whether improved bowel management through TAI is associated with changes in gut microbiota and whether these changes correlate with clinical outcomes.
Participants will be followed for 24 months with standardized clinical evaluations and microbiological assessments performed according to the study protocol. The findings are expected to provide new evidence regarding the role of transanal irrigation in the management of constipation associated with Parkinson's disease and to improve understanding of the relationship between bowel function, the gut microbiome, and disease manifestations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study, subjects must fulfil all of the following criteria:
- •Provision of informed consent.
- •Female or male aged 18 years or above.
- •Established diagnosis of PD according to MDS criteria
- •Patients with bowel symptoms post-dating and related to a diagnosis of PD.
- •PD patients suffering from constipation defined by Cleveland Clinic (Wexner) constipation score ≥10 confirmed at Baseline.
- •Only TAI treatment naïve patient (not having previously used any particular TAI system).
- •Judged eligible for TAI as per standardized treatment pathway .
- •Able to read, write and understand information given to them regarding the study.
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Any confirmed or suspected diagnosis of anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
- •Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-PD related neuro complications).
- •Opioid consumption ≤24 hours prior enrolment.
- •Taking probiotics in the past 30 days.
- •Antibiotic therapy in the past 3 weeks.
- •Performed endoscopic polypectomy within 4 weeks prior enrolment.
- •Ongoing, confirmed pregnancy or lactation.
- •Any neuromodulation that can affect the pelvic organ function.
- •Current treatment of prokinetics.
- •Any other condition, as judged by the investigator, might make follow-up or investigations inappropriate.
- •Exclusion Criteria:
研究组 & 干预措施
Standard Bowel Care (SBC)
Participants randomized to this arm will receive standard bowel care (SBC), including lifestyle advice and recommendations for laxative agents as clinically indicated. Subjects will have the same frequency of contact with the investigator or delegate as the experimental arm, including scheduled on-site visits at Baseline, 6 months, and 24 months, and telephone follow-ups at 1 month and 12 months.
干预措施: Standard Bowel Care (Other)
Transanal Irrigation (TAI) with Qufora Flow Device
Participants randomized to this arm will receive transanal irrigation (TAI) using the Qufora Flow device. Subjects will be trained in proper device use after randomization. Treatment is administered as part of routine management of neurogenic bowel dysfunction in Parkinson's disease. Participants will attend scheduled on-site visits at Baseline, 6 months, and 24 months, and will complete telephone follow-ups at 1 month and 12 months.
干预措施: Transanal Irrigation System (Device)
结局指标
主要结局
Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
时间窗: Baseline, 6 months, and 24 months.
Constipation severity will be assessed using the Cleveland Clinic Constipation Score (Wexner Constipation Score). The score ranges from 0 to 30, where higher scores indicate more severe constipation. The outcome measure will be the change from baseline in total score at each assessment.
次要结局
- Change From Baseline in Hoehn and Yahr Stage(Baseline, 6 months, and 24 months.)
- Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score(Baseline, 6 months, and 24 months.)
- Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score(Baseline, 6 months, and 24 months.)
- Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score)(Baseline, 6 months, and 24 months.)
- Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS)(Baseline, 6 months, and 24 months.)
- Treatment Adherence(Baseline, 6 months, and 24 months.)
- Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies(From randomization until 24 months.)
- Change in Gut Microbiota Composition(Baseline, 6 months, and 24 months)
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score(Baseline, 6 months, and 24 months.)
- Change From Baseline in Montreal Cognitive Assessment (MoCA) Score(Baseline, 6 months, and 24 months.)
- Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score(Baseline, 6 months, and 24 months.)
- Change From Baseline in SCOPA-AUT Total Score(Baseline, 6 months, and 24 months.)
- Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index(Baseline, 6 months, and 24 months.)
- Change From Baseline in Levodopa Equivalent Daily Dose (LEDD)(Baseline, 6 months, and 24 months.)
研究者
Simona Ascanelli
General Surgeon
University Hospital of Ferrara