Double-blind, placebo-controlled, cross-over trial of LivauxTM for the treatment of constipation and microbiome restoration in Parkinson’s disease.

Not Applicable

• Conditions: Parkinson's Disease; Constipation; Neurological - Parkinson's disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000991910
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-01
• Study Completion: 2022-09-13
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1.Diagnosis of Parkinson’s disease according to UK Parkinson’s Disease Society Brain Bank Diagnostic Criteria
2.Currently meet ROME IV criteria for functional constipation
3.Experience 3 or fewer bowel motion days per week
4.18 years or older
5.BMI range 19-35
6.Prepared to maintain current dietary habits for the duration of the study

Exclusion Criteria

1.Allergy to Kiwifruit
2.Allergy to latex
3.Clinically significant (as defined by local PI) gastrointestinal disorders not limited to:
•Inflammatory Bowel Disease
•History of major GI surgery
•Structural or metabolic diseases affecting GI system
4.Other identifiable cause of constipation such as other neurological diseases, peripheral neuropathy, iatragenic constipation
5.Clinically significant or respiratory, cardiac failure or other concurrent medical conditions as defined by local PI
6.Current or recent use (within 2 weeks of baseline) of probiotics including
•Probiotic yoghurt or probiotic yoghurt drinks,
•fermented foods such as sauerkraut, tempeh, kimchi, miso, pickles
•fermented drinks such as kombucha
7.Current or recent use (within 2 weeks of baseline) of the following medications:
•Opiate analgesics
•Artane
•Cogentin
•Drugs with a low therapeutic index (warfarin, digoxin)
•Antacids containing magnesium or aluminium salts
•Anticholinergics
•Antibiotics (within 6 weeks of baseline)
•SSRIs, SNRIs, or Tricyclic antidepressants (unless on a stable dosing regime)
8.History of laxative abuse
9.A high-fibre diet defined by >50g fibre per day
10.High fibre supplements
11.Females of child-bearing potential

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the number of complete bowel motions (CBM) per week (CBM defined as a bowel movement after which a feeling of complete evacuation is reported). [End of treatment periods at week 6 and 16]