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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04293159
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : May 20, 2022
Sponsor:
Collaborators:
Roberto Erro
Maria Teresa Pellecchia
Antonella Santonicola
Carolina Ciacci
Information provided by (Responsible Party):
PAOLA IOVINO, University of Salerno

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Constipation Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®) Not Applicable

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 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)
Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)




Primary Outcome Measures :
  1. satisfaction with therapy [ Time Frame: 12 weeks ]
    A "satisfaction with therapy" score (on a 7-point Likert scale: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = dissatisfied, 4 = partially satisfied, 5 = satisfied, 6 = very satisfied, 7 = extremely satisfied)

  2. Improvement after treatment [ Time Frame: 12 WEEKS ]

    "Improvement after treatment" was evaluated with a global rating-of-change scale (-7 to +7: -7 = extremely worsened, 0 = unchanged,

    +7 = extremely improved). "Improvement after treatment" was defined by an increase in the global rating-of-change scale of ≥2 points.


  3. neuropsychological function [ Time Frame: 12 weeks ]
    The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD.The total NMSS score ranges from 0 to 360, the worst.


Secondary Outcome Measures :
  1. the Unified Parkinson Disease Rating Scale (UPDRS, italian version) [ Time Frame: 12 WEEKS ]
    the Unified Parkinson Disease Rating Scale (UPDRS, italian version). The UPDRS is a rating tool used to gauge the course of Parkinson's disease in patients. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability); The Non-motor-symptoms scale (NMSS, italian version)

  2. M-PAC SYM [ Time Frame: 12 WEEKS ]
    M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293159


Contacts
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Contact: PAOLA IOVINO, MD +39 3357822672 piovino@unisa.it

Locations
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Italy
Aou Sangiovanni E Ruggi D'Aragona Recruiting
Salerno, Italy, 84000
Sponsors and Collaborators
University of Salerno
Roberto Erro
Maria Teresa Pellecchia
Antonella Santonicola
Carolina Ciacci
Investigators
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Principal Investigator: PAOLA IOVINO, MD University of Salerno
Publications of Results:

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Responsible Party: PAOLA IOVINO, Associate Professor, University of Salerno
ClinicalTrials.gov Identifier: NCT04293159    
Other Study ID Numbers: University of Salerno
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PAOLA IOVINO, University of Salerno:
constipation
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Signs and Symptoms, Digestive