Effect of Probiotic on Constipation in Patients With Parkinson's Disease
NCT ID: NCT04293159
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-05-14
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)
Interventions
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Lactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)
Eligibility Criteria
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Inclusion Criteria
* Negative for colon cancer screening
* Negative relevant additional screening or consultation whenever appropriate.
* Ability of conforming to the study protocol.
* Stable treatment for Parkinson's disease
Exclusion Criteria
* Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
* Previous major abdominal surgeries.
* Inability to conform with protocol.
* Recent history or suspicion of alcohol abuse or drug addiction.
* Previous participation in this study.
18 Years
75 Years
ALL
No
Sponsors
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Roberto Erro
UNKNOWN
Maria Teresa Pellecchia
UNKNOWN
Antonella Santonicola
UNKNOWN
Carolina Ciacci
UNKNOWN
University of Salerno
OTHER
Responsible Party
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PAOLA IOVINO
Associate Professor
Principal Investigators
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PAOLA IOVINO, MD
Role: PRINCIPAL_INVESTIGATOR
University of Salerno
Locations
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Aou Sangiovanni E Ruggi D'Aragona
Salerno, , Italy
Countries
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Central Contacts
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References
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Erro R, Picillo M, Vitale C, Amboni M, Moccia M, Longo K, Cozzolino A, Giordano F, De Rosa A, De Michele G, Pellecchia MT, Barone P. Non-motor symptoms in early Parkinson's disease: a 2-year follow-up study on previously untreated patients. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):14-7. doi: 10.1136/jnnp-2012-303419. Epub 2012 Sep 19.
Fasano A, Visanji NP, Liu LW, Lang AE, Pfeiffer RF. Gastrointestinal dysfunction in Parkinson's disease. Lancet Neurol. 2015 Jun;14(6):625-39. doi: 10.1016/S1474-4422(15)00007-1.
Martinez-Martinez MI, Calabuig-Tolsa R, Cauli O. The effect of probiotics as a treatment for constipation in elderly people: A systematic review. Arch Gerontol Geriatr. 2017 Jul;71:142-149. doi: 10.1016/j.archger.2017.04.004. Epub 2017 Apr 14.
Bellini M, Usai-Satta P, Bove A, Bocchini R, Galeazzi F, Battaglia E, Alduini P, Buscarini E, Bassotti G; ChroCoDiTE Study Group, AIGO. Chronic constipation diagnosis and treatment evaluation: the "CHRO.CO.DI.T.E." study. BMC Gastroenterol. 2017 Jan 14;17(1):11. doi: 10.1186/s12876-016-0556-7.
Neri L, Iovino P; Laxative Inadequate Relief Survey (LIRS) Group. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation. Neurogastroenterol Motil. 2016 Apr;28(4):581-91. doi: 10.1111/nmo.12758. Epub 2016 Feb 12.
Cappello C, Tremolaterra F, Pascariello A, Ciacci C, Iovino P. A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life. Int J Colorectal Dis. 2013 Mar;28(3):349-58. doi: 10.1007/s00384-012-1552-1. Epub 2012 Aug 12.
Other Identifiers
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University of Salerno
Identifier Type: -
Identifier Source: org_study_id
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