Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04554641
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2020-09-04
Brief Title:
Effect of a Multi Strain Probiotic on the Gut Microbiota
Sponsor:
The Functional Gut Clinic
Organization:
The Functional Gut Clinic
Study Overview
Official Title:
The Effect of a Multi-strain Live Bacteria Supplement on the Gut Microbiota Composition of Healthy Adults an Open Label Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over recent years there has been a lot of research looking at how the bacteria in our gut affect our health Changes to gut bacteria has been linked to several diseases Taking specific live bacteria supplements sometimes known as probiotics to change the balance of our gut bacteria to result in a health benefit have been trialled as a treatment option for many diseases in recent years
Bio-Kult Advanced is a live bacteria Food supplement that contains 14 different bacteria cultures The effect of Bio-Kult Advanced on gut bacteria is unknown therefore the aim
Bio-Kult Advanced is a live bacteria Food supplement that contains 14 different bacteria cultures The effect of Bio-Kult Advanced on gut bacteria is unknown therefore the aim
Detailed Description:
There is rapidly growing interest in the involvement of the microbiome in health Imbalance in human gut microbiota dysbiosis has been linked to several diseases Manipulation of the microbiome using specific strains of live micro-organisms that confer a health benefit on the host probiotics have therefore become an exploratory treatment option in microbiome-associated diseases in recent years Numerous studies have shown selected strains of bacteria to show statistically significant and clinically relevant improvement in symptoms in a number of diseases including but not limited to infantile colic and atopic dermatitis
Bio-Kult Advanced BKA is a 14 strain live bacteria supplement containing a Minimum 2 billion live microorganisms per capsule 2x109 CFUcapsule equivalent to 10 billion live microorganisms per gram 1x1010 CFUgram A randomised controlled trial of Bio-Kult Advanced in the management of diarrhoea predominant IBS demonstrated significant improvement in gastrointestinal GI symptoms and was well tolerated by participants Another randomised controlled trial of Bio-Kult Advanced in participants with episodic and chronic migraine sufferers demonstrated significant improvement in frequency and severity of migraines compared to placebo This clinical effectiveness across various conditions suggest that bacterial strains in Bio-Kult could have an effect on the gastrointestinal flora however data has yet to be collected that explores the effect of Bio-Kult on the microbiome The aim of this study is to therefore investigate the effect of Bio-Kult Advanced on the composition of the gut microbiota in healthy adults
Bio-Kult Advanced BKA is a 14 strain live bacteria supplement containing a Minimum 2 billion live microorganisms per capsule 2x109 CFUcapsule equivalent to 10 billion live microorganisms per gram 1x1010 CFUgram A randomised controlled trial of Bio-Kult Advanced in the management of diarrhoea predominant IBS demonstrated significant improvement in gastrointestinal GI symptoms and was well tolerated by participants Another randomised controlled trial of Bio-Kult Advanced in participants with episodic and chronic migraine sufferers demonstrated significant improvement in frequency and severity of migraines compared to placebo This clinical effectiveness across various conditions suggest that bacterial strains in Bio-Kult could have an effect on the gastrointestinal flora however data has yet to be collected that explores the effect of Bio-Kult on the microbiome The aim of this study is to therefore investigate the effect of Bio-Kult Advanced on the composition of the gut microbiota in healthy adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None