Microbial ColonizationNCT04554641
Effect of a Multi Strain Probiotic on the Gut Microbiota
A study testing Fasted breath samples, Daily Diary and Stool sample in people with Microbial Colonization, run by The Functional Gut Clinic at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Fasted breath samples, Daily Diary and Stool sample
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 12 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Fasted breath samples, Daily Diary, Stool sample
- Keywords
- Probiotics, Microbiome, Gastrointestinal
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted breath samplesOther
Participants will provide fasted breath samples pre and post Bio-Kult Advanced.
Daily DiaryOther
Monitoring stool form, consistency and frequency on a daily basis.
Stool sampleOther
Participants will provide stool sample pre and post Bio-kult Advanced.
| Study group | Role | What they receive |
|---|---|---|
| BioKult Advanced | Experimental | 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. Receives: Other: Fasted breath samples; Other: Daily Diary; Other: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool sample comparison
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.
Measured: 56 days
Secondary outcomes (2)
Fasting breath samples
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).
Measured: 56 days
Bowel habit
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).
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Nov 2019
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Functional Gut Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- ADM Protexin
- Responsible party
- Principal investigator, Dr Anthony Hobson, The Functional Gut Clinic
- Investigators
- Anthony Hobson, Principal investigator, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554641
- Sponsor's protocol ID
- FGC-19-003
- Status last verified
- Feb 2021
- First submitted
- 4 Sep 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-strain Live Bacteria Supplement on the Gut Microbiota Composition of Healthy Adults: an Open Label Trial
- ClinicalTrials.gov ID
- NCT04554641
- Acronym / sponsor ID
- FGC-19-003
- Conditions
- Microbial Colonization
- Keywords
- Probiotics, Microbiome, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Functional Gut ClinicUniversity, hospital or other
- Collaborators
- ADM Protexin
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioKult Advanced | Experimental | Other: Fasted breath samples, Other: Daily Diary, Other: Stool sampleThis 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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:
- unilateral location
- pulsating character
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasted breath samplesParticipants will provide fasted breath samples pre and post Bio-Kult Advanced. | Other | BioKult Advanced |
| Daily DiaryMonitoring stool form, consistency and frequency on a daily basis. | Other | BioKult Advanced |
| Stool sampleParticipants will provide stool sample pre and post Bio-kult Advanced. | Other | BioKult Advanced |
Primary outcome
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.
2 secondary outcomes
Fasting breath samples
Time frame: 56 days
Bowel habit
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Hobson principal investigator
The Functional Gut Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasted breath samples, Daily Diary and Stool sample in people with Microbial Colonization, run by The Functional Gut Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool sample comparison (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.