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Completed

NCT Number: NCT02459717

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Neurologico Mondino

Pavia, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Probiotics and prebiotic

Other

Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

Placebo

Other

Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)

Primary outcomes

  1. Complete bowel movements

    Time frame: 4 weeks

    Change in the mean number of complete spontaneous bowel movements

Secondary outcomes

  1. Number of bowel movements

    Time frame: 4 weeks

    Change in the mean number of spontaneous bowel movements

  2. Stool consistency

    Time frame: 4 weeks

    Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)

  3. Laxative use

    Time frame: 4 weeks

    Change in the mean use of laxative

  4. Treatment satisfaction

    Time frame: 4 weeks

    Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale

  5. Treatment continuation

    Time frame: 4 weeks

    Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

  6. Increase in one or more complete bowel movements

    Time frame: 4 weeks

    Percentage of patients reporting an increase in one or more complete bowel movements

  7. Frequency of three or more complete bowel movements

    Time frame: 4 weeks

    Percentage of patients reporting three or more complete bowel movements

Sponsors and collaborators

Lead sponsor

Emanuele Cereda

Other

Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation
  • Istituti Clinici di Perfezionamento di Milano

Registry information

Official study title

Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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