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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Synbiotic

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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.
Placebo Comparator: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systemic inflammatory profile	Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	6 weeks

Collaborators and Investigators

• Sponsor: Elizabeth Simpson
• Investigators: Principal Investigator: Amrita Vijay, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): December 22, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FMHS 314-0623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data arising from the current study will be fully anonymised and used for publication purposes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No