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

Elizabeth Simpson

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Synbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06480812

FMHS 314-0623

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Synbiotic arm

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Synbiotic

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Synbiotic