Constipation, Parkinson Disease
Conditions
Keywords
Parkinson, Constipation, Transanal Irrigation, Gut Micriobiome, TAI
Brief summary
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.
Detailed description
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.
Interventions
DEVICETransanal 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.
OTHERStandard 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.
Sponsors
University Hospital of Ferrara
Azienda Policlinico Umberto I
Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine
ISS Istituto per la Sicurezza Sociale, San Marino
Hospital of Prato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For inclusion in the study, subjects must fulfil all of the following criteria: 1. Provision of informed consent. 2. Female or male aged 18 years or above. 3. Established diagnosis of PD according to MDS criteria 4. Patients with bowel symptoms post-dating and related to a diagnosis of PD. 5. PD patients suffering from constipation defined by Cleveland Clinic (Wexner) constipation score ≥10 confirmed at Baseline. 6. Only TAI treatment naïve patient (not having previously used any particular TAI system). 7. Judged eligible for TAI as per standardized treatment pathway . 8. Able to read, write and understand information given to them regarding the study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score | Baseline, 6 months, and 24 months. | Quality of life related to constipation will be assessed using the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The total score ranges from 0 to 4, with higher scores indicating poorer constipation-related quality of life. The outcome measure will be the change from baseline in total score. |
| Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score | Baseline, 6 months, and 24 months. | Bowel dysfunction severity will be assessed using the Neurogenic Bowel Dysfunction (NBD) Score. The score ranges from 0 to 47, with higher scores indicating more severe bowel dysfunction. The outcome measure will be the change from baseline in total score. |
| Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score) | Baseline, 6 months, and 24 months. | Fecal incontinence severity will be assessed using the Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score). The score ranges from 0 to 20, with higher scores indicating more severe fecal incontinence. The outcome measure will be the change from baseline in total score. |
| Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS) | Baseline, 6 months, and 24 months. | Patient satisfaction with bowel management and study treatment will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where higher scores indicate greater satisfaction. The outcome measure will be the change from baseline. |
| Treatment Adherence | Baseline, 6 months, and 24 months. | Treatment adherence will be assessed as the number and percentage of participants remaining on the assigned study treatment (TAI or standard bowel care) at each follow-up visit. |
| Change From Baseline in Hoehn and Yahr Stage | Baseline, 6 months, and 24 months. | Disease severity will be assessed using the Hoehn and Yahr staging scale. The scale ranges from Stage 1 to Stage 5, with higher stages indicating more advanced Parkinson's disease. The outcome measure will be the change from baseline in disease stage. |
| Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies | From randomization until 24 months. | Safety will be assessed by recording the number of participants experiencing adverse events (AEs), serious adverse events (SAEs), and device deficiencies during the study period. |
| Change in Gut Microbiota Composition | Baseline, 6 months, and 24 months | Gut microbiota composition will be assessed from stool samples using microbiological sequencing analysis. Changes in microbial composition and diversity from baseline will be compared between treatment groups. |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | Baseline, 6 months, and 24 months. | Motor and non-motor symptoms will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The total score ranges from 0 to 272, with higher scores indicating greater severity of Parkinson's disease symptoms. The outcome measure will be the change from baseline in the total score. |
| Change From Baseline in Montreal Cognitive Assessment (MoCA) Score | Baseline, 6 months, and 24 months. | Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure will be the change from baseline in total score. |
| Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score | Baseline, 6 months, and 24 months. | Non-motor symptoms will be assessed using the Non-Motor Symptoms Scale (NMSS). The total score ranges from 0 to 360, with higher scores indicating a greater burden of non-motor symptoms. The outcome measure will be the change from baseline in total score. |
| Change From Baseline in SCOPA-AUT Total Score | Baseline, 6 months, and 24 months. | Autonomic symptoms will be assessed using the Scale for Outcomes in Parkinson's Disease for Autonomic Symptoms (SCOPA-AUT). The total score ranges from 0 to 69, with higher scores indicating more severe autonomic dysfunction. The outcome measure will be the change from baseline in total score. |
| Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index | Baseline, 6 months, and 24 months. | Health-related quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The Summary Index ranges from 0 to 100, with higher scores indicating poorer quality of life. The outcome measure will be the change from baseline in the Summary Index. |
| Change From Baseline in Levodopa Equivalent Daily Dose (LEDD) | Baseline, 6 months, and 24 months. | The Levodopa Equivalent Daily Dose (LEDD), expressed in milligrams per day (mg/day), will be recorded to assess changes in dopaminergic therapy during the study. The outcome measure will be the change from baseline in LEDD. |
Countries
Italy
Contacts
CONTACTSimona Ascanelli, Medical Doctor
Outcome results
None listed