Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transanal Irrigation System
  Transanal irrigation performed using a CE-marked transanal irrigation system (Irrisedo Flow, Qufora, Allerød, Denmark) for the management of neurogenic bowel dysfunction in patients with Parkinson's disease. Participants randomized to this arm will receive training on device use and will perform irrigation according to clinical practice and individual needs throughout the study period.
• Другое Standard Bowel Care
  Standard bowel care including lifestyle advice (dietary and behavioral recommendations) and the use of laxative agents as clinically indicated. Participants will receive the same frequency of clinical follow-up as the experimental arm.

Первичные конечные точки

• Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score) [Срок оценки: Baseline, 6 months, and 24 months.]

Вторичные конечные точки (12)

• Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score) [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS) [Срок оценки: Baseline, 6 months, and 24 months.]
• Treatment Adherence [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in Hoehn and Yahr Stage [Срок оценки: Baseline, 6 months, and 24 months.]
• Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies [Срок оценки: From randomization until 24 months.]
• Change in Gut Microbiota Composition [Срок оценки: Baseline, 6 months, and 24 months]
• Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in Montreal Cognitive Assessment (MoCA) Score [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score [Срок оценки: Baseline, 6 months, and 24 months.]
• Change From Baseline in SCOPA-AUT Total Score [Срок оценки: Baseline, 6 months, and 24 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• University Hospital Ferrara — Ferrara

Публикации

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Идентификаторы

NCT: NCT07716553 · 187/2025/Disp/AOUFe

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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