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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293159
• Other study ID #: University of Salerno
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: University of Salerno
• Contact: PAOLA IOVINO, MD
• Phone: +39 3357822672
• Email: piovino[@]unisa.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Italy	Aou Sangiovanni E Ruggi D'Aragona	Salerno

Sponsors (5)

Lead Sponsor	Collaborator
University of Salerno	Antonella Santonicola, Carolina Ciacci, Maria Teresa Pellecchia, Roberto Erro

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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 — View Citation

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 M — View Citation

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 Neuro — View Citation

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. Review. — View Citation

Martínez-Martínez MI, Calabuig-Tolsá 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. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	the Unified Parkinson Disease Rating Scale (UPDRS, italian version)	the Unified Parkinson Disease Rating Scale (UPDRS, italian version). The UPDRS is a rating tool used to gauge the course of Parkinson's disease in patients. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability); The Non-motor-symptoms scale (NMSS, italian version)	12 WEEKS
Secondary	M-PAC SYM	M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong)	12 WEEKS