Effect of Probiotic on Constipation in Patients With Parkinson's Disease

NCT ID: NCT04293159

Last Updated: 2022-05-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-14

Study Completion Date

2023-06-30

Brief Summary

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The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance

Detailed Description

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The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis® duo) effect on overall abdominal pain, bowel movements and other abdominal symptoms and on neuropsychological performance in patients with Parkinson's Disease. The investigators suppose that, due to the immunomodulatory action of probiotics, overall neuropsychological function will improve as well as due also to prebiotic abdominal symptoms will decrease following consumption of Lactobacillus casei DG (Enterolactis® duo).

Conditions

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Parkinson Disease Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactobacillus casei DG (Enterolactis duo®)

Lactobacillus casei DG (Enterolactis duo®)

Group Type EXPERIMENTAL

Lactobacillus casei DG (Enterolactis duo®)

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus casei DG (Enterolactis duo®)

Interventions

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Lactobacillus casei DG (Enterolactis duo®)

Lactobacillus casei DG (Enterolactis duo®)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtype constipation according to Rome IV 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

* Presence of any other relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values a part from Parkinson's disease
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roberto Erro

UNKNOWN

Sponsor Role collaborator

Maria Teresa Pellecchia

UNKNOWN

Sponsor Role collaborator

Antonella Santonicola

UNKNOWN

Sponsor Role collaborator

Carolina Ciacci

UNKNOWN

Sponsor Role collaborator

University of Salerno

OTHER

Sponsor Role lead

Responsible Party

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PAOLA IOVINO

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Italy

Central Contacts

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PAOLA IOVINO, MD

Role: CONTACT

+39 3357822672

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.

Reference Type RESULT
PMID: 22993448 (View on PubMed)

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.

Reference Type RESULT
PMID: 25987282 (View on PubMed)

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.

Reference Type RESULT
PMID: 28467916 (View on PubMed)

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.

Reference Type RESULT
PMID: 28088179 (View on PubMed)

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.

Reference Type RESULT
PMID: 26867677 (View on PubMed)

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.

Reference Type RESULT
PMID: 22885882 (View on PubMed)

Other Identifiers

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University of Salerno

Identifier Type: -

Identifier Source: org_study_id

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