Effect of a Multi Strain Probiotic on the Gut Microbiota

Status Completed

Clinical Trial 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

Clinical Trial 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 CFU/capsule), equivalent to 10 billion live microorganisms per gram (1x1010 CFU/gram). 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04554641
Study type	Interventional
Source	The Functional Gut Clinic
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2019
Completion date	February 12, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.