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

NCT07716553 | Not Yet Recruiting DMC

• 1 other identifier: 187/2025/Disp/AOUFe
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if transanal irrigation (TAI) works better than standard bowel care (SBC) to treat severe constipation in people with Parkinson's disease (PD). It will also evaluate its effects on gut microbiota and motor disorders, as well as its safety. The main questions it aims to answer are: Does TAI improve constipation more than standard bowel care? Does TAI have an effect on gut microbiota composition? Does TAI influence motor and non-motor symptoms in Parkinson's disease? What side effects or safety issues occur with TAI? Researchers will compare TAI using the Qufora Flow device to standard bowel care (including diet, fluids, and medications) to see which approach is more effective. Participants will: Be randomly assigned to TAI or standard bowel care Perform TAI every other day or follow standard bowel care routines Attend clinic visits at the start, after 6 months, and after 24 months Receive follow-up phone calls after 1 month and 12 months Complete questionnaires on bowel function, quality of life, and Parkinson's symptoms Provide stool samples to analyze gut microbiota Keep a food diary and record treatments

Conditions

Parkinson Disease; Constipation

Keywords

Parkinson; Constipation; Transanal Irrigation; Gut Micriobiome; TAI

Outcome Measures

Primary Outcomes (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.

  Baseline, 6 months, and 24 months.

Secondary Outcomes (14)

• 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.

Study Arms (2)

Transanal Irrigation (TAI) with Qufora Flow Device

EXPERIMENTAL

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.

Device: Transanal Irrigation System

Standard Bowel Care (SBC)

ACTIVE COMPARATOR

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.

Other: Standard Bowel Care

Interventions

Standard Bowel Care OTHER

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.

Standard Bowel Care (SBC)

Transanal Irrigation System DEVICE

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.

Transanal Irrigation (TAI) with Qufora Flow Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Azienda Policlinico Umberto I: collaborator
• Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine: collaborator
• ISS Istituto per la Sicurezza Sociale, San Marino: collaborator
• Hospital of Prato: collaborator

Study Sites (1)

University Hospital Ferrara

Ferrara, Ferrara, 44100, Italy

Location

Related Publications (37)

• 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.

  PMID: 41855756 BACKGROUND

• 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.

  PMID: 23193283 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 27214047 BACKGROUND

• 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.

  PMID: 31341288 BACKGROUND

• 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.

  PMID: 22333067 BACKGROUND

• 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.

  PMID: 37680746 BACKGROUND

• 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.

  PMID: 15152600 BACKGROUND

• 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.

  PMID: 11875684 BACKGROUND

• 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.

  PMID: 16952543 BACKGROUND

• 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.

  PMID: 34689840 BACKGROUND

• 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.

  PMID: 9351479 BACKGROUND

• 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.

  PMID: 19780808 BACKGROUND

• 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.

  PMID: 30949554 BACKGROUND

• 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.

  PMID: 17115387 BACKGROUND

• Dalrymple-Alford JC, MacAskill MR, Nakas CT, Livingston L, Graham C, Crucian GP, Melzer TR, Kirwan J, Keenan R, Wells S, Porter RJ, Watts R, Anderson TJ. The MoCA: well-suited screen for cognitive impairment in Parkinson disease. Neurology. 2010 Nov 9;75(19):1717-25. doi: 10.1212/WNL.0b013e3181fc29c9.

  PMID: 21060094 BACKGROUND

• Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8. doi: 10.1002/mds.20213.

  PMID: 15372591 BACKGROUND

• Voutilainen A, Pitkaaho T, Kvist T, Vehvilainen-Julkunen K. How to ask about patient satisfaction? The visual analogue scale is less vulnerable to confounding factors and ceiling effect than a symmetric Likert scale. J Adv Nurs. 2016 Apr;72(4):946-57. doi: 10.1111/jan.12875. Epub 2015 Dec 22.

  PMID: 26689434 BACKGROUND

• Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.

  PMID: 16036506 BACKGROUND

• Zangaglia R, Martignoni E, Glorioso M, Ossola M, Riboldazzi G, Calandrella D, Brunetti G, Pacchetti C. Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study. Mov Disord. 2007 Jul 15;22(9):1239-44. doi: 10.1002/mds.21243.

  PMID: 17566120 BACKGROUND

• Magnuson FS, Christensen P, Krassioukov A, Rodriguez G, Emmanuel A, Kirshblum S, Krogh K. Neurogenic Bowel Dysfunction in Patients with Spinal Cord Injury and Multiple Sclerosis-An Updated and Simplified Treatment Algorithm. J Clin Med. 2023 Nov 7;12(22):6971. doi: 10.3390/jcm12226971.

  PMID: 38002586 BACKGROUND

• Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, 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 UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

  PMID: 19025984 BACKGROUND

• Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. doi: 10.1007/BF02056950.

  PMID: 8646957 BACKGROUND

• Ascanelli S, Bombardini C, Chimisso L, Carcoforo P, Turroni S, D'Amico F, Caniati ML, Baldi E, Tugnoli V, Morotti C, Valpiani G, Bazzocchi G. Trans-anal irrigation in patients with multiple sclerosis: Efficacy in treating disease-related bowel dysfunctions and impact on the gut microbiota: A monocentric prospective study. Mult Scler J Exp Transl Clin. 2022 Jul 6;8(3):20552173221109771. doi: 10.1177/20552173221109771. eCollection 2022 Jul-Sep.

  PMID: 35832690 BACKGROUND

• Mozaffari S, Nikfar S, Daniali M, Abdollahi M. The pharmacological management of constipation in patients with Parkinson's disease: a much-needed relief. Expert Opin Pharmacother. 2020 Apr;21(6):701-707. doi: 10.1080/14656566.2020.1726319. Epub 2020 Feb 8.

  PMID: 32037901 BACKGROUND

• Mathers SE, Kempster PA, Swash M, Lees AJ. Constipation and paradoxical puborectalis contraction in anismus and Parkinson's disease: a dystonic phenomenon? J Neurol Neurosurg Psychiatry. 1988 Dec;51(12):1503-7. doi: 10.1136/jnnp.51.12.1503.

  PMID: 3221217 BACKGROUND

• van Kessel SP, de Jong HR, Winkel SL, van Leeuwen SS, Nelemans SA, Permentier H, Keshavarzian A, El Aidy S. Gut bacterial deamination of residual levodopa medication for Parkinson's disease. BMC Biol. 2020 Oct 20;18(1):137. doi: 10.1186/s12915-020-00876-3.

  PMID: 33076930 BACKGROUND

• Fasano A, Bove F, Gabrielli M, Petracca M, Zocco MA, Ragazzoni E, Barbaro F, Piano C, Fortuna S, Tortora A, Di Giacopo R, Campanale M, Gigante G, Lauritano EC, Navarra P, Marconi S, Gasbarrini A, Bentivoglio AR. The role of small intestinal bacterial overgrowth in Parkinson's disease. Mov Disord. 2013 Aug;28(9):1241-9. doi: 10.1002/mds.25522. Epub 2013 May 27.

  PMID: 23712625 BACKGROUND

• Zhang X, Han Y, Huang W, Jin M, Gao Z. The influence of the gut microbiota on the bioavailability of oral drugs. Acta Pharm Sin B. 2021 Jul;11(7):1789-1812. doi: 10.1016/j.apsb.2020.09.013. Epub 2020 Sep 28.

  PMID: 34386321 BACKGROUND

• Hey G, Nair N, Klann E, Gurrala A, Safarpour D, Mai V, Ramirez-Zamora A, Vedam-Mai V. Therapies for Parkinson's disease and the gut microbiome: evidence for bidirectional connection. Front Aging Neurosci. 2023 May 30;15:1151850. doi: 10.3389/fnagi.2023.1151850. eCollection 2023.

  PMID: 37323145 BACKGROUND

• Ohkusa T, Koido S, Nishikawa Y, Sato N. Gut Microbiota and Chronic Constipation: A Review and Update. Front Med (Lausanne). 2019 Feb 12;6:19. doi: 10.3389/fmed.2019.00019. eCollection 2019.

  PMID: 30809523 BACKGROUND

• Kleine Bardenhorst S, Cereda E, Severgnini M, Barichella M, Pezzoli G, Keshavarzian A, Desideri A, Pietrucci D, Aho VTE, Scheperjans F, Hildebrand F, Weis S, Egert M, Karch A, Vital M, Rubsamen N. Gut microbiota dysbiosis in Parkinson disease: A systematic review and pooled analysis. Eur J Neurol. 2023 Nov;30(11):3581-3594. doi: 10.1111/ene.15671. Epub 2023 Jan 18.

  PMID: 36593694 BACKGROUND

• Vascellari S, Melis M, Palmas V, Pisanu S, Serra A, Perra D, Santoru ML, Oppo V, Cusano R, Uva P, Atzori L, Morelli M, Cossu G, Manzin A. Clinical Phenotypes of Parkinson's Disease Associate with Distinct Gut Microbiota and Metabolome Enterotypes. Biomolecules. 2021 Jan 22;11(2):144. doi: 10.3390/biom11020144.

  PMID: 33499229 BACKGROUND

• Wang Q, Luo Y, Ray Chaudhuri K, Reynolds R, Tan EK, Pettersson S. The role of gut dysbiosis in Parkinson's disease: mechanistic insights and therapeutic options. Brain. 2021 Oct 22;144(9):2571-2593. doi: 10.1093/brain/awab156.

  PMID: 33856024 BACKGROUND

• Skjaerbaek C, Knudsen K, Horsager J, Borghammer P. Gastrointestinal Dysfunction in Parkinson's Disease. J Clin Med. 2021 Jan 31;10(3):493. doi: 10.3390/jcm10030493.

  PMID: 33572547 BACKGROUND

• Emmanuel A. Managing neurogenic bowel dysfunction. Clin Rehabil. 2010 Jun;24(6):483-8. doi: 10.1177/0269215509353253.

  PMID: 20511302 BACKGROUND

• Sakakibara R. Gastrointestinal dysfunction in movement disorders. Neurol Sci. 2021 Apr;42(4):1355-1365. doi: 10.1007/s10072-021-05041-4. Epub 2021 Feb 4.

  PMID: 33538914 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simona Ascanelli, Medical Doctor

CONTACT

+39 0532 236316; simona.ascanelli@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)