Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease (TAI-PD)
28 lipca 2026 zaktualizowane przez: Simona Ascanelli, University Hospital of Ferrara
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.
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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
200
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Simona Ascanelli, Medical Doctor
- Numer telefonu: +39 0532 236316
- E-mail: simona.ascanelli@unife.it
Lokalizacje studiów
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Ferrara
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Ferrara, Ferrara, Włochy, 44100
- University Hospital Ferrara
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Aktywny komparator: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score
Ramy czasowe: 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.
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Baseline, 6 months, and 24 months.
|
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Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score
Ramy czasowe: 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.
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Baseline, 6 months, and 24 months.
|
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Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score)
Ramy czasowe: 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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS)
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Treatment Adherence
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in Hoehn and Yahr Stage
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies
Ramy czasowe: From randomization until 24 months.
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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.
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From randomization until 24 months.
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Change in Gut Microbiota Composition
Ramy czasowe: Baseline, 6 months, and 24 months
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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.
|
Baseline, 6 months, and 24 months
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Ramy czasowe: 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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in Montreal Cognitive Assessment (MoCA) Score
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in SCOPA-AUT Total Score
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Ramy czasowe: Baseline, 6 months, and 24 months.
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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.
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Baseline, 6 months, and 24 months.
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Change From Baseline in Levodopa Equivalent Daily Dose (LEDD)
Ramy czasowe: 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.
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Baseline, 6 months, and 24 months.
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Współpracownicy i badacze
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Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 września 2026
Zakończenie podstawowe (Szacowany)
30 września 2028
Ukończenie studiów (Szacowany)
30 września 2029
Daty rejestracji na studia
Pierwszy przesłany
3 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
15 lipca 2026
Pierwszy wysłany (Rzeczywisty)
21 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 187/2025/Disp/AOUFe
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .