Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-04 @ 12:10 AM
Study NCT ID:
NCT06480812
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
Sponsor:
Elizabeth Simpson
Organization:
Study Overview
Official Title:
The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: