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Completed

NCT Number: NCT06480812

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synbiotic

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in gut microbiome profile

    Time frame: 6 weeks

    Change in gut microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period

  2. Changes in short chain fatty acids (SCFAs)

    Time frame: 6 weeks

    Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period

  3. Mental Wellbeing as measured by validated questionnaires

    Time frame: 6 weeks

    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

  4. Changes in skin microbiome profile

    Time frame: 6 weeks

    Change in skin microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period

Sponsors and collaborators

Lead sponsor

Elizabeth Simpson

Other

Registry information

Official study title

The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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