Status:
UNKNOWN
Effect of Probiotic on Constipation in Patients With Parkinson's Disease
Lead Sponsor:
University of Salerno
Collaborating Sponsors:
Roberto Erro
Maria Teresa Pellecchia
Conditions:
Parkinson Disease
Constipation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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
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 neuro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04293159
Start Date
May 14 2019
End Date
June 1 2023
Last Update
May 20 2022
Active Locations (1)
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1
Aou Sangiovanni E Ruggi D'Aragona
Salerno, Italy, 84000