NCT04293159

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 14, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

3.6 years

First QC Date

February 19, 2020

Last Update Submit

May 18, 2022

Conditions

Parkinson DiseaseConstipation

Keywords

constipationParkinson's disease

Outcome Measures

Primary Outcomes (3)

  • satisfaction with therapy

    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)

    12 weeks

  • Improvement after treatment

    "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.

    12 WEEKS

  • neuropsychological function

    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.

    12 weeks

Secondary Outcomes (2)

  • the Unified Parkinson Disease Rating Scale (UPDRS, italian version)

    12 WEEKS

  • M-PAC SYM

    12 WEEKS

Study Arms (1)

Lactobacillus casei DG (Enterolactis duo®)

EXPERIMENTAL

Lactobacillus casei DG (Enterolactis duo®)

Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)

Interventions

Lactobacillus casei DG (Enterolactis duo®)DIETARY_SUPPLEMENT

Lactobacillus casei DG (Enterolactis duo®)

Lactobacillus casei DG (Enterolactis duo®)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aou Sangiovanni E Ruggi D'Aragona

Salerno, 84000, Italy

RECRUITING

Related Publications (6)

  • Erro R, Picillo M, Vitale C, Amboni M, Moccia M, Longo K, Cozzolino A, Giordano F, De Rosa A, De Michele G, Pellecchia MT, Barone P. Non-motor symptoms in early Parkinson's disease: a 2-year follow-up study on previously untreated patients. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):14-7. doi: 10.1136/jnnp-2012-303419. Epub 2012 Sep 19.

    PMID: 22993448RESULT

  • Fasano A, Visanji NP, Liu LW, Lang AE, Pfeiffer RF. Gastrointestinal dysfunction in Parkinson's disease. Lancet Neurol. 2015 Jun;14(6):625-39. doi: 10.1016/S1474-4422(15)00007-1.

    PMID: 25987282RESULT

  • Martinez-Martinez MI, Calabuig-Tolsa R, Cauli O. The effect of probiotics as a treatment for constipation in elderly people: A systematic review. Arch Gerontol Geriatr. 2017 Jul;71:142-149. doi: 10.1016/j.archger.2017.04.004. Epub 2017 Apr 14.

    PMID: 28467916RESULT

  • Bellini M, Usai-Satta P, Bove A, Bocchini R, Galeazzi F, Battaglia E, Alduini P, Buscarini E, Bassotti G; ChroCoDiTE Study Group, AIGO. Chronic constipation diagnosis and treatment evaluation: the "CHRO.CO.DI.T.E." study. BMC Gastroenterol. 2017 Jan 14;17(1):11. doi: 10.1186/s12876-016-0556-7.

    PMID: 28088179RESULT

  • Neri L, Iovino P; Laxative Inadequate Relief Survey (LIRS) Group. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation. Neurogastroenterol Motil. 2016 Apr;28(4):581-91. doi: 10.1111/nmo.12758. Epub 2016 Feb 12.

    PMID: 26867677RESULT

  • Cappello C, Tremolaterra F, Pascariello A, Ciacci C, Iovino P. A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life. Int J Colorectal Dis. 2013 Mar;28(3):349-58. doi: 10.1007/s00384-012-1552-1. Epub 2012 Aug 12.

    PMID: 22885882RESULT

MeSH Terms

Conditions

Parkinson DiseaseConstipation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • PAOLA IOVINO, MD

    University of Salerno

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PAOLA IOVINO, MD

CONTACT

+39 3357822672piovino@unisa.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 19, 2020

First Posted

March 3, 2020

Study Start

May 14, 2019

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations

IT(1)