HealthyNCT06480812
The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
A study testing Synbiotic in people with Healthy, run by Elizabeth Simpson at 1 site in United Kingdom.
Trial summary
The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2023to 22 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
- Have a smart phone in order to download apps on phone
Who cannot join
- Have any gastrointestinal condition or food intolerance which could impact ability to comply with the intervention (e.g. IBS, malabsorptive conditions such as IBD, coeliac)
- Have lactose intolerance
- Have diabetes mellitus or any condition with an inflammatory component such as asthma, psoriasis, arthritis etc.
- Are currently taking fibre or probiotic supplements
- Are taking any prescribed medication
- Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
Show all 10Show fewer
- Are pregnant or breast feeding
- Currently have a diagnosed psychiatric illness
- History or current neurological condition (e.g. epilepsy)
- Have taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study
The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.
Read the detailed description
The aim of this study is to generate high quality pilot data examining the role of a combination of pre and probiotic (synbiotic) supplementation in improving metabolic health (particularly systemic inflammation) and quality of life.
Specific Aim 1: To deliver a wealth of data, including effect sizes, on the physiological effects of synbiotic supplementation on the changes in the microbiome and metabolomic profile of an individual.
Specific Aim 2: To investigate potential mechanisms whereby the gut microbiome modulates crucial physiological parameters such as inflammatory markers and mental well-being measures.
- Conditions
- Healthy
- Being tested
- Synbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
The proposed protocol will provide a simple but robust intervention study using a synbiotic (pre and probiotic combination) in order to improve our understanding of the mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.
This pilot study will comprise a controlled randomised intervention in which participants will be grouped into the active synbiotic arm or the control arm. The ratios will be 10g of the prebiotic supplement and 170ml of kefir. Randomisation will control for equal distribution of age and biological sex; characteristics that may confound between group comparisons and will be assessed by analysis of baseline data.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic arm | Active comparator | Synbiotic mixure (10g prebiotic fibre + 170ml kefir) will be randomly allocated to eligible participants in order to test specific effects of the synbiotic mixture on gut microbiome composition and metabolic markers. Receives: Dietary Supplement: Synbiotic |
| Control | Placebo comparator | Individuals in the control arm will not be provided with the test supplement and asked to carry on with their usual diet and lifestyle. Receives: Dietary Supplement: Synbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic inflammatory profile
Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period.
Measured: 6 weeks
Secondary outcomes (4)
Change in gut microbiome profile
Change in gut microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period
Measured: 6 weeks
Changes in short chain fatty acids (SCFAs)
Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period
Measured: 6 weeks
Mental Wellbeing as measured by validated questionnaires
The Hospital Anxiety and Depression Survey (HADS) was used to assess subjective measures of anxiety and depression. The scores for each subscale (HADS-Anxiety (A) and HADS-Depression (D)) range from 0 to 21. The cut-off scores range from:
0-7: Normal (no significant symptoms) 8-10: Borderline or mild symptoms 11-21: Clinically significant anxiety or depression
Measured: 6 weeks
Changes in skin microbiome profile
Change in skin microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start24 Jul 2023
- Primary completion12 Jun 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Simpson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Amrita Vijay, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480812
- Sponsor's protocol ID
- FMHS 314-0623
- Status last verified
- May 2025
- First submitted
- 24 Jun 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data arising from the current study will be fully anonymised and used for publication purposes
Publications
Vijay A, Simpson L, Tooley M, Turley S, Kouraki A, Kelly A, Menni C, Armstrong J, Jones S, Valdes AM. The anti-inflammatory effects of three different dietary supplement interventions. J Transl Med. 2025 Oct 16;23(1):1081. doi: 10.1186/s12967-025-07167-x.
PubMed 41094562
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT06480812
- Acronym / sponsor ID
- FMHS 314-0623
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Elizabeth SimpsonUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 28 Jun 2024 (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.
The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.
Detailed description
The aim of this study is to generate high quality pilot data examining the role of a combination of pre and probiotic (synbiotic) supplementation in improving metabolic health (particularly systemic inflammation) and quality of life.
Specific Aim 1: To deliver a wealth of data, including effect sizes, on the physiological effects of synbiotic supplementation on the changes in the microbiome and metabolomic profile of an individual.
Specific Aim 2: To investigate potential mechanisms whereby the gut microbiome modulates crucial physiological parameters such as inflammatory markers and mental well-being measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled
| Arm | Type | Receives |
|---|---|---|
| Synbiotic arm | Active comparator | Dietary Supplement: SynbioticSynbiotic mixure (10g prebiotic fibre + 170ml kefir) will be randomly allocated to eligible participants in order to test specific effects of the synbiotic mixture on gut microbiome composition and metabolic markers. |
| Control | Placebo comparator | Dietary Supplement: SynbioticIndividuals in the control arm will not be provided with the test supplement and asked to carry on with their usual diet and lifestyle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study
- Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
- Have a smart phone in order to download apps on phone
Key exclusion criteria (10 listed)
- Have any gastrointestinal condition or food intolerance which could impact ability to comply with the intervention (e.g. IBS, malabsorptive conditions such as IBD, coeliac)
- Have lactose intolerance
- Have diabetes mellitus or any condition with an inflammatory component such as asthma, psoriasis, arthritis etc.
- Are currently taking fibre or probiotic supplements
- Are taking any prescribed medication
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 |
|---|---|---|
| SynbioticThe proposed protocol will provide a simple but robust intervention study using a synbiotic (pre and probiotic combination) in order to improve our understanding of the mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome. This pilot study will comprise a controlled randomised intervention in which participants will be grouped into the active synbiotic arm or the control arm. The ratios will be 10g of the prebiotic supplement and 170ml of kefir. Randomisation will control for equal distribution of age and biological sex; characteristics that may confound between group comparisons and will be assessed by analysis of baseline data. | Dietary supplement | Control, Synbiotic arm |
Primary outcome
Change in systemic inflammatory profile
Time frame: 6 weeks
Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period.
4 secondary outcomes
Change in gut microbiome profile
Time frame: 6 weeks
Changes in short chain fatty acids (SCFAs)
Time frame: 6 weeks
Mental Wellbeing as measured by validated questionnaires
Time frame: 6 weeks
Changes in skin microbiome profile
Time frame: 6 weeks
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 15 May 2025.
- Derived from this study: PubMed 41094562Vijay A, Simpson L, Tooley M, Turley S, Kouraki A, Kelly A, Menni C, Armstrong J, Jones S, Valdes AM. The anti-inflammatory effects of three different dietary supplement interventions. J Transl Med. 2025 Oct 16;23(1):1081. doi: 10.1186/s12967-025-07167-x.
- Individual participant dataSharing planned: No. All data arising from the current study will be fully anonymised and used for publication purposes
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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.
Amrita Vijay, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Healthy, run by Elizabeth Simpson 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 3 inclusion and 10 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 15 May 2025. 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. Some participants in this study may receive a placebo. 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?
Change in systemic inflammatory profile (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480812, which also lists 1 linked publication.
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 15 May 2025.