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

NCT06480812 | Completed

• 1 other identifier: FMHS 314-0623
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in gut microbiome profile

  6 weeks

• Changes in short chain fatty acids (SCFAs)

  6 weeks

• Mental Wellbeing as measured by validated questionnaires

  6 weeks

• Changes in skin microbiome profile

  6 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Synbiotic

Interventions

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.

Control; Synbiotic arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Simpson: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41094562 DERIVED

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Amrita Vijay, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: Randomised Controlled

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: July 24, 2023
• Primary Completion: June 12, 2024
• Study Completion: December 22, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)