The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome

NCT ID: NCT06480812

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2024-12-22

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Synbiotic arm

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.

Group Type: ACTIVE_COMPARATOR

Synbiotic

Intervention Type: DIETARY_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.

Control

Individuals in the control arm will not be provided with the test supplement and asked to carry on with their usual diet and lifestyle.

Group Type: PLACEBO_COMPARATOR

Synbiotic

Intervention Type: DIETARY_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.

Interventions

Synbiotic

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elizabeth Simpson

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Simpson

Senior Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amrita Vijay, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University of Nottingham

Nottingham, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 41094562 (View on PubMed)

Other Identifiers

FMHS 314-0623

Identifier Type: -

Identifier Source: org_study_id