Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease (TAI-PD)
28. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Simona Ascanelli, Medical Doctor
- Telefonnummer: +39 0532 236316
- E-post: simona.ascanelli@unife.it
Studiesteder
-
-
Ferrara
-
Ferrara, Ferrara, Italia, 44100
- University Hospital Ferrara
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Aktiv 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score)
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS)
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Treatment Adherence
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Hoehn and Yahr Stage
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies
Tidsramme: 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.
|
From randomization until 24 months.
|
|
Change in Gut Microbiota Composition
Tidsramme: 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.
|
Baseline, 6 months, and 24 months
|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in SCOPA-AUT Total Score
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
|
Change From Baseline in Levodopa Equivalent Daily Dose (LEDD)
Tidsramme: 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.
|
Baseline, 6 months, and 24 months.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- R Core Team (2023). _R: A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Emmanuel A. Managing neurogenic bowel dysfunction. Clin Rehabil. 2010 Jun;24(6):483-8. doi: 10.1177/0269215509353253.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
30. september 2028
Studiet fullført (Antatt)
30. september 2029
Datoer for studieregistrering
Først innsendt
3. juli 2026
Først innsendt som oppfylte QC-kriteriene
15. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Synukleinopatier
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Tegn og symptomer, fordøyelseskanal
- Nevrodegenerative sykdommer
- Bevegelsesforstyrrelser
- Parkinsonlidelser
- Basal ganglia sykdommer
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Parkinsons sykdom
- Forstoppelse
Andre studie-ID-numre
- 187/2025/Disp/AOUFe
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .