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

Not Applicable

• Conditions: Parkinson Disease; Constipation
• Interventions: Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)

• Registration Number: NCT04293159
• Lead Sponsor: 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

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).

Study Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-20
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactobacillus casei DG (Enterolactis duo®)	Lactobacillus casei DG (Enterolactis duo®)	Lactobacillus casei DG (Enterolactis duo®)

Primary Outcome Measures

Name	Time	Method
Improvement after treatment	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.
neuropsychological function	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.
satisfaction with therapy	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)

Secondary Outcome Measures

Name	Time	Method
the Unified Parkinson Disease Rating Scale (UPDRS, italian version)	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)
M-PAC SYM	12 WEEKS	M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong)

Trial Locations

Locations (1)

Aou Sangiovanni E Ruggi D'Aragona; 🇮🇹 Salerno, Italy