Effect of a Multi Strain Probiotic on the Gut Microbiota

February 15, 2021 updated by: Dr Anthony Hobson, The Functional Gut Clinic

The Effect of a Multi-strain Live Bacteria Supplement on the Gut Microbiota Composition of Healthy Adults: an Open Label Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M2 4NG
        • The Functional Gut Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult males and females (50:50) between 18 to 40 years old
  • No significant medical diagnosis (healthy individuals)
  • Not on regular prescription medicines
  • No selective/restricted diets (e.g. vegan, low FODMAP)
  • Body Mass Index of 18.50-29.99 kg/m2
  • Participant able to understand the participant information sheet in English and provide informed consent

Exclusion Criteria:

  • Diagnosis of any medical condition, except for visual impairment and other conditions to clinicians discretion
  • Prior abdominal surgery (e.g. appendectomy, bariatric surgery )

  • Migraine as based on migraine definition by ICHD 2019:

    • A minimum of five attacks (in absolute terms) fulfilling criteria:

      • Duration 4 - 72 hours
      • At least two of the following:
  • unilateral location
  • pulsating character
  • moderate or severe pain intensity
  • aggravation by routine physical activity
  • Presence of nausea/vomiting OR photophobia/phonophobia during headache

  • Ongoing therapy with medication known to affect the gut microbiome:

    • Antibiotics used in the last 8 weeks
    • Proton pump inhibitors used in the last 8 weeks
    • Antidepressants in the last 8 weeks
    • Regular use of laxatives or anti-diarrheal medications
  • Alcohol consumption >14 units per week
  • Pregnancy or breastfeeding
  • Vegan and other selective diets, use of diet replacements (e.g. Huel)
  • Regular consumption of probiotics, prebiotics, fibre supplements or any use of probiotics in 2 months prior enrolment
  • Unwillingness to exclude other probiotic products from diet during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BioKult Advanced
This is a single arm study, all participants will take Bio-kult Advanced for 56 days (+/- 2days). Participants will be required to take 4 capsules daily.
Other: Fasted breath samples
Participants will provide fasted breath samples pre and post Bio-Kult Advanced.
Other: Daily Diary
Monitoring stool form, consistency and frequency on a daily basis.
Other: Stool sample
Participants will provide stool sample pre and post Bio-kult Advanced.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stool sample comparison
Time Frame: 56 days
Comparison between samples at different taxonomical levels (phylum, family, genus and species) will be performed for the identification of specific bacteria in samples of interest. Accumulative bar charts will be provided for rapid inspection. PCA and clustering will be conducted. Biodiversity Index (Shannon, Simpson, Gini-Simpson or Berger-Parker) will be calculated. Biostatistics will be done in order to detect biomarkers between timepoints of the study.
56 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting breath samples
Time Frame: 56 days
Mean change in fasted breath hydrogen and methane, will be determined from baseline to end of study. Mean fasted hydrogen and mean fasted methane will be calculated independently of one each other. Breath hydrogen and breath methane will be measured in units of parts per million (ppm). Statistical significance will be determined using a paired t-test (p<0.05).
56 days
Bowel habit
Time Frame: 56 days
Mean difference in stool frequency and consistency from baseline and end of study will be determined using a paired t-test, to determine significance (p<0.05).
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Functional Gut Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ADM Protexin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FGC-19-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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