None listed
Conditions
Brief summary
Approximately one quarter of Australians suffer from constipation symptoms. Current treatments including fiber supplements, laxatives, and prescription medication are not effective for all people and have been associated with adverse events. There is recent evidence showing that excess methane production which is a gas produced by some people in the stomach or gut may be important in slowing colonic transit or the time it takes for food to travel through your digestive system in some people with constipation. A new treatment that has been shown to be effective in some people with constipation are probiotics. Probiotics are live microorganisms that are intended to have health benefits. Further research however is needed to find out whether different types of probiotics are effective in treating constipation and what are the underlying reasons for their effectiveness including whether they work by reducing methane gas levels. This study aims to test in whether a novel therapy of probiotics is effective in the treatment of constipation symptoms and methane production levels as determined by a breath test and chemical analysis in 90 patients attending a gastroenterology outpatient clinic with constipation.
Interventions
A single center, randomized, double-blind, controlled study in which patients are randomised to placebo, and different doses of a patented mixture of probiotic strains.
Patients will be randomised according to a random block procedure at between 1 and 4 weeks after the baseline assessment to receive either for 30 days a probiotic strain mixture at a dose of 25 billion Colony-forming units in diffusion chambers (cfu/d) with food or probiotics at a dose of 50 billion Colony-forming units in di
A single center, randomized, double-blind, controlled study in which patients are randomised to placebo, and different doses of a patented mixture of probiotic strains. Patients will be randomised according to a random block procedure at between 1 and 4 weeks after the baseline assessment to receive either for 30 days a probiotic strain mixture at a dose of 25 billion Colony-forming units in diffusion chambers (cfu/d) with food or probiotics at a dose of 50 billion Colony-forming units in diffusion chambers (cfu/d) with food or identical placebo. Probiotic - Bifidobacterium lactis SFI 105 B. longum SFI 009 Lactobacillus plantarum SFI 219 L. rhamnosus SFI 220 L. acidophilus SFI 201 L. casei SFI 207 L. reuteri SFI 223 Adherence will be monitored by drug tablet return
Sponsors
Metro South Hosptial and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
18 years of age and older Presence of constipation symptoms for at least 6 months and in the first instance a baseline methane exhalations > 10 ppm.
Exclusion criteria
Patients younger than 18 years and older than 80 years of age. Exclusion of any relevant conditions that can interfere with the study objectives including: Medical co morbidities that are related to constipation Diagnosis of diabetes Previous surgery that may account for constipation Receiving ongoing antibiotic treatment
Outcome results
None listed