Clinical Trials Directory

Trials / Completed

CompletedNCT02431533

The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome

The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome: A Randomized, Double-Blind Placebo Controlled Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Pharmabiotix Inc · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

IBS is a disorder of movement in the gut. People who have IBS may have diarrhea, constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often the only way doctors can diagnose it is to rule out other conditions through testing.

Detailed description

Probiotics, particularly Bifidobacterium infantis, Sacchromyces boulardii, Lactobacillus plantarum and combination probiotics may help regulate how often people with IBS have bowel movements. Probiotics may also help relieve bloating from gas. Research is continuing to determine which probiotics are best to treat IBS. PX0612 PX0612 is a probiotic which is composed of the following ingredients contained in a veggie capsule, being one dose: Bacillus coagulans 200 million colony forming units 16.0mg Bacillus subtilis 100 million colony forming units 4.8mg Enterococcus faecium 100 million colony forming units 0.6mg Fructo-oligosacharride a nutrient for the packaged product 600.0mg Total 621.4 mg Bacillus coagulans is a non-pathogenic, Gram positive, spore forming bacteria that produces lactic acid. Though not normally found in the gut. Bacillus coagulans strains have been used as general nutritional supplements and agents to control constipation and diarrhea in humans and animals.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPX0612PX0612 is a probiotic contained in a veggie capsule.
DIETARY_SUPPLEMENTDi-Calcium PhosphatePatients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate

Timeline

Start date
2016-01-01
Primary completion
2018-08-01
Completion
2018-08-01
First posted
2015-05-01
Last updated
2020-06-12
Results posted
2019-10-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02431533. Inclusion in this directory is not an endorsement.