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

University of Salerno

Status: Unknown

Conditions: Parkinson Disease; Constipation

Treatments: Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04293159

University of Salerno

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lactobacillus casei DG (Enterolactis duo®)

Experimental group

Description:

Lactobacillus casei DG (Enterolactis duo®)

Treatment:

Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)