Pre-biotics and Probiotics for Constipation in Parkinson's Disease

Emanuele Cereda

Status: Completed

Conditions: Constipation

Treatments: Other: Probiotics and prebiotic; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02459717

66/INT/2015

Details and patient eligibility

About

Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of constipation according to Roma III criteria
• complete bowel movements per week <3
• total bowel movements per week <6
• written informed consent

Exclusion criteria

• report of loose (mushy) or watery stool in the absence of laxative use
• ongoing artificial nutrition
• lactose intolerance
• chronic inflammatory bowel disease
• previous abdominal surgery
• use of anti-cholinergics
• use of antibiotics in the 6 weeks before baseline visit
• Radio- chemotherapy
• Cognitive decline (Mini Mental State Examination <27)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Probiotics and prebiotic

Experimental group

Description:

fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

Treatment:

Other: Probiotics and prebiotic

Placebo

Placebo Comparator group

Description:

pasteurized fermented milk (125 grams) without prebiotics

Treatment:

Other: Placebo