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Parkinson DiseaseTAI-PDNCT07716553

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

A study testing Transanal Irrigation System and Standard Bowel Care in people with Parkinson Disease and Constipation, run by University Hospital of Ferrara at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Constipation
What is being tested?
Transanal Irrigation System and Standard Bowel Care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteItaly
Study dates
30 Sep 2026to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Simona Ascanelli, Medical Doctor contact

+39 0532 236316

simona.ascanelli@unife.it

Italy1 site

  • University Hospital Ferrara

    Ferrara, Ferrara, 44100

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Transanal Irrigation System, Standard Bowel Care
Keywords
Parkinson, Constipation, Transanal Irrigation, Gut Micriobiome, TAI
Medical subject headings
Parkinson Disease, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transanal Irrigation SystemDevice

    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.

  • Standard Bowel CareOther

    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.

Study groups in NCT07716553
Study groupRoleWhat they receive
Transanal Irrigation (TAI) with Qufora Flow DeviceExperimentalParticipants 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.
Receives: Device: Transanal Irrigation System
Standard Bowel Care (SBC)Active comparatorParticipants 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.
Receives: Other: Standard Bowel Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)

    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.

    Measured: Baseline, 6 months, and 24 months.

Secondary outcomes (14)

  1. Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score

    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.

    Measured: Baseline, 6 months, and 24 months.

  2. Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score

    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.

    Measured: Baseline, 6 months, and 24 months.

  3. Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score)

    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.

    Measured: Baseline, 6 months, and 24 months.

  4. Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS)

    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.

    Measured: Baseline, 6 months, and 24 months.

  5. Treatment Adherence

    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.

    Measured: Baseline, 6 months, and 24 months.

  6. Change From Baseline in Hoehn and Yahr Stage

    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.

    Measured: Baseline, 6 months, and 24 months.

  7. Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies

    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.

    Measured: From randomization until 24 months.

  8. Change in Gut Microbiota Composition

    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.

    Measured: Baseline, 6 months, and 24 months

  9. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    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.

    Measured: Baseline, 6 months, and 24 months.

  10. Change From Baseline in Montreal Cognitive Assessment (MoCA) Score

    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.

    Measured: Baseline, 6 months, and 24 months.

  11. Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score

    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.

    Measured: Baseline, 6 months, and 24 months.

  12. Change From Baseline in SCOPA-AUT Total Score

    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.

    Measured: Baseline, 6 months, and 24 months.

  13. Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index

    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.

    Measured: Baseline, 6 months, and 24 months.

  14. Change From Baseline in Levodopa Equivalent Daily Dose (LEDD)

    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.

    Measured: Baseline, 6 months, and 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716553
Sponsor's protocol ID
187/2025/Disp/AOUFe
Acronym
TAI-PD
Status last verified
Jul 2026
First submitted
3 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Colucci F, Ascanelli S, Chimisso L, Antenucci P, Procaccianti G, Mechelli A, Gozzi A, Rossin E, D'Amico F, Turroni S, Azzolina D, Sensi M. Transanal Irrigation in patients with Parkinson's Disease and chronic constipation: rebalancing the Gut Microbiota? Parkinsonism Relat Disord. 2026 May;146:108289. doi: 10.1016/j.parkreldis.2026.108289. Epub 2026 Mar 17. No abstract available.

    PubMed 41855756

  • Quast C, Pruesse E, Yilmaz P, Gerken J, Schweer T, Yarza P, Peplies J, Glockner FO. The SILVA ribosomal RNA gene database project: improved data processing and web-based tools. Nucleic Acids Res. 2013 Jan;41(Database issue):D590-6. doi: 10.1093/nar/gks1219. Epub 2012 Nov 28.

    PubMed 23193283

  • R Core Team (2023). _R: A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/

  • Callahan BJ, McMurdie PJ, Rosen MJ, Han AW, Johnson AJ, Holmes SP. DADA2: High-resolution sample inference from Illumina amplicon data. Nat Methods. 2016 Jul;13(7):581-3. doi: 10.1038/nmeth.3869. Epub 2016 May 23.

    PubMed 27214047

  • Bolyen E, Rideout JR, Dillon MR, Bokulich NA, Abnet CC, Al-Ghalith GA, Alexander H, Alm EJ, Arumugam M, Asnicar F, Bai Y, Bisanz JE, Bittinger K, Brejnrod A, Brislawn CJ, Brown CT, Callahan BJ, Caraballo-Rodriguez AM, Chase J, Cope EK, Da Silva R, Diener C, Dorrestein PC, Douglas GM, Durall DM, Duvallet C, Edwardson CF, Ernst M, Estaki M, Fouquier J, Gauglitz JM, Gibbons SM, Gibson DL, Gonzalez A, Gorlick K, Guo J, Hillmann B, Holmes S, Holste H, Huttenhower C, Huttley GA, Janssen S, Jarmusch AK, Jiang L, Kaehler BD, Kang KB, Keefe CR, Keim P, Kelley ST, Knights D, Koester I, Kosciolek T, Kreps J, Langille MGI, Lee J, Ley R, Liu YX, Loftfield E, Lozupone C, Maher M, Marotz C, Martin BD, McDonald D, McIver LJ, Melnik AV, Metcalf JL, Morgan SC, Morton JT, Naimey AT, Navas-Molina JA, Nothias LF, Orchanian SB, Pearson T, Peoples SL, Petras D, Preuss ML, Pruesse E, Rasmussen LB, Rivers A, Robeson MS 2nd, Rosenthal P, Segata N, Shaffer M, Shiffer A, Sinha R, Song SJ, Spear JR, Swafford AD, Thompson LR, Torres PJ, Trinh P, Tripathi A, Turnbaugh PJ, Ul-Hasan S, van der Hooft JJJ, Vargas F, Vazquez-Baeza Y, Vogtmann E, von Hippel M, Walters W, Wan Y, Wang M, Warren J, Weber KC, Williamson CHD, Willis AD, Xu ZZ, Zaneveld JR, Zhang Y, Zhu Q, Knight R, Caporaso JG. Reproducible, interactive, scalable and extensible microbiome data science using QIIME 2. Nat Biotechnol. 2019 Aug;37(8):852-857. doi: 10.1038/s41587-019-0209-9. No abstract available.

    PubMed 31341288

  • Masella AP, Bartram AK, Truszkowski JM, Brown DG, Neufeld JD. PANDAseq: paired-end assembler for illumina sequences. BMC Bioinformatics. 2012 Feb 14;13:31. doi: 10.1186/1471-2105-13-31.

    PubMed 22333067

  • Roggiani S, Zama D, D'Amico F, Rocca A, Fabbrini M, Totaro C, Pierantoni L, Brigidi P, Turroni S, Lanari M. Gut, oral, and nasopharyngeal microbiota dynamics in the clinical course of hospitalized infants with respiratory syncytial virus bronchiolitis. Front Cell Infect Microbiol. 2023 Aug 23;13:1193113. doi: 10.3389/fcimb.2023.1193113. eCollection 2023.

    PubMed 37680746

  • Yu Z, Morrison M. Improved extraction of PCR-quality community DNA from digesta and fecal samples. Biotechniques. 2004 May;36(5):808-12. doi: 10.2144/04365ST04.

    PubMed 15152600

  • Riegler G, Esposito I. Bristol scale stool form. A still valid help in medical practice and clinical research. Tech Coloproctol. 2001 Dec;5(3):163-4. doi: 10.1007/s101510100019.

    PubMed 11875684

  • Christensen P, Bazzocchi G, Coggrave M, Abel R, Hultling C, Krogh K, Media S, Laurberg S. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006 Sep;131(3):738-47. doi: 10.1053/j.gastro.2006.06.004.

    PubMed 16952543

  • Nyholm D, Jost WH. An updated calculator for determining levodopa-equivalent dose. Neurol Res Pract. 2021 Oct 25;3(1):58. doi: 10.1186/s42466-021-00157-6.

    PubMed 34689840

  • Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.

    PubMed 9351479

  • Rodriguez-Blazquez C, Forjaz MJ, Frades-Payo B, de Pedro-Cuesta J, Martinez-Martin P; Longitudinal Parkinson's Disease Patient Study, Estudio Longitudinal de Pacients con Enfermedad da Parkinson Group. Independent validation of the scales for outcomes in Parkinson's disease-autonomic (SCOPA-AUT). Eur J Neurol. 2010 Feb;17(2):194-201. doi: 10.1111/j.1468-1331.2009.02788.x. Epub 2009 Sep 23.

    PubMed 19780808

  • Martinez-Martin P, Schrag A, Weintraub D, Rizos A, Rodriguez-Blazquez C, Chaudhuri KR; IPMDS Non Motor PD Study Group. Pilot Study of the International Parkinson and Movement Disorder Society-sponsored Non-motor Rating Scale (MDS-NMS). Mov Disord Clin Pract. 2019 Feb 5;6(3):227-234. doi: 10.1002/mdc3.12728. eCollection 2019 Mar.

    PubMed 30949554

  • Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. doi: 10.1002/mds.21198.

    PubMed 17115387

Questions about this trial

What is this clinical trial studying?

A study testing Transanal Irrigation System and Standard Bowel Care in people with Parkinson Disease and Constipation, run by University Hospital of Ferrara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Simona Ascanelli, Medical Doctor (+39 0532 236316, simona.ascanelli@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score) (time frame: Baseline, 6 months, and 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07716553, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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