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

Last updated: May 18, 2022
Sponsor: University of Salerno
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Treatment

N/A

Clinical Study ID

NCT04293159
University of Salerno
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtypeconstipation 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

Exclusion Criteria:

  • Presence of any other relevant organic, systemic or metabolic disease (particularlysignificant history of cardiac, renal, oncology, endocrinology, metabolic or hepaticdisease), or abnormal laboratory values that will be deemed clinically significant onthe basis of predefined values a part from Parkinson's disease
  • Ascertained intestinal organic diseases, including ascertained celiac disease orinflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulardisease, 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.

Study Design

Total Participants: 30
Study Start date:
May 14, 2019
Estimated Completion Date:
June 30, 2023

Study 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 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).

Connect with a study center

  • Aou Sangiovanni E Ruggi D'Aragona

    Salerno, 84000
    Italy

    Active - Recruiting

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