Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease (TAI-PD)
2026년 7월 28일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Simona Ascanelli, Medical Doctor
- 전화번호: +39 0532 236316
- 이메일: simona.ascanelli@unife.it
연구 장소
-
-
Ferrara
-
Ferrara, Ferrara, 이탈리아, 44100
- University Hospital Ferrara
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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:
-
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 30일
기본 완료 (추정된)
2028년 9월 30일
연구 완료 (추정된)
2029년 9월 30일
연구 등록 날짜
최초 제출
2026년 7월 3일
QC 기준을 충족하는 최초 제출
2026년 7월 15일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 28일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 187/2025/Disp/AOUFe
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .