NCT02459717

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 1, 2025

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

May 26, 2015

Last Update Submit

April 29, 2025

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • Complete bowel movements

    Change in the mean number of complete spontaneous bowel movements

    4 weeks

Secondary Outcomes (7)

  • Number of bowel movements

    4 weeks

  • Stool consistency

    4 weeks

  • Laxative use

    4 weeks

  • Treatment satisfaction

    4 weeks

  • Treatment continuation

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Probiotics and prebiotic

EXPERIMENTAL

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

Other: Probiotics and prebiotic

Placebo

PLACEBO COMPARATOR

pasteurized fermented milk (125 grams) without prebiotics

Other: Placebo

Interventions

Probiotics and prebioticOTHER

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

Probiotics and prebiotic
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Neurologico Mondino

Pavia, Italy

Location

Related Publications (2)

  • Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.

    PMID: 39470206DERIVED

  • Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.

    PMID: 27543643DERIVED

MeSH Terms

Conditions

Constipation

Interventions

ProbioticsPrebiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharides

Study Officials

  • Claudio Pacchetti, MD

    IRCCS Istituto Neurologico Mondino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-project Investigator

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 1, 2025

Record last verified: 2015-10

Locations

IT(1)