Microbiome of the Ageing Gut and Its Effect on Human Gut Health and Cognition.

NCT04199195 | Active Not Recruiting DMC

• 1 other identifier: QIB04-2018
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to undertake a 49-month longitudinal study in a cohort of 360 healthy individuals of 60 years and older, living in East Anglia to understand the role of gut microbes (the microbiome) in healthy ageing. The investigators also aim to identify changes in the structure and function of the gut microbe populations that are associated with deteriorating mental health and cognitive function. Using clinically validated cognitive assessments and tests, study participants will be stratified in to one of three risk groups for developing dementia:- Cohort 1 - low (n=120). Cohort 2 - medium (n=120). Cohort 3 - high (n=120). Participants will be recruited from three streams - Primary Care, The NHS Bowel Cancer Screening Programme (BCSP) and the Norfolk \& Suffolk Foundation Trust (NSFT). Following initial Telephone Contact and the Pre-Study Visit, all participants will be required to attend the Quadram Institute Clinical Research Facility (QI CRF) every 6 months over 4 years. At each of these follow-up visits, the participant will provide a stool sample (collected at home) and at differing time points, provide a blood sample and undergo a series of physical measurements, cognitive tests/questionnaires and complete a health questionnaire. All participants will undergo Optical Coherence Tomography scans at the Beccles \& District War Memorial Hospital. There will be 2 subgroups in this study. Subgroup 1 - at least 30 participants from each cohort (n= at least 90) will undergo colonic tissue biopsies as part of routine clinical care using the NHS BCSP. Subgroup 2 - 30 participants from Cohort 3 will undergo brain imaging at the Norfolk \& Norwich University Hospital (NNUH) Imaging Department. The results of the study will provide new insights into the gut-brain axis and the relationship between age-associated changes in gut microbe populations and declining mental health. Such insights will be of enormous value in developing new microbe-based strategies to improve lifelong health and wellbeing that impact on dementia development.

Conditions

Ageing

Outcome Measures

Primary Outcomes (1)

• Microbial composition

  Changes in microbiome measured by DNA/RNA sequencing of longitudinal samples collected at 6 monthly intervals.

  48 months

Secondary Outcomes (2)

• Establishment of a biorepository

  48 months

• Microbial signatures identified and correlated with measures of declining health and (organ) functionality.

  48 months

Study Arms (1)

Males and females aged at least 60 years.

A longitudinal study of one cohort of 360 participants aged at least 60 years. Participants will be required to provide a stool sample, provide a blood sample and complete a health questionnaire every 6 months for 4 years. At alternate visits, participants will be required to under go cognitive assessments and physical measurements. Participants will be required to under go an Optical Coherence Tomography Scan 3 times over 4 years. Sub group 1 - During a routine care colonoscopy, at least 90 participants will have 6-8 colon tissue biopsies taken for research purposes. Sub group 2 - Participants from cohort 3 only will be offered an optional brain MRI until the required number of 30 participants is achieved.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females aged at least 60 years without existing serious health conditions at the point of providing informed consent.

You may qualify if:

• Male or female aged at least 60 years.
• Must be able to provide informed consent.
• Must be able to complete the Cognitive Tests/Questionnaires, Health Questionnaires by themselves and be familiar with using an ipad/tablet.

You may not qualify if:

• Currently taking part in an interventional study.
• Living with or related to any member of the research team.
• Have a diagnosis of Dementia, Parkinson's Disease, Alzheimer's Disease, Creutzfeldt-Jakob disease (CJD), Picks Disease.
• Bipolar Disorder.
• Obsessive Compulsive Disorder.
• Untreated current clinical depression.
• Have irreversible brain injury.
• Have had a stroke.
• Have epilepsy.
• Take more than a daily dose of probiotics.
• Have a long-standing gastrointestinal or liver function abnormality requiring on- going medical management or medication.
• History of cancer within the last 5 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
• Unstable dietary history as defined by major changes in diet during the previous month, where a major food group in the diet has been stopped or significantly increased, for example become vegetarian, vegan or stopped eating red meat.
• History of alcohol, drug or substance abuse. History of Hepatitis B or Hepatitis C.
• Major surgery of the gastrointestinal tract, apart from gall bladder or appendix removal, in the past five years.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Related Publications (1)

• Phillips S, Watt R, Atkinson T, Rajan S, Hayhoe A, Savva GM, Hornberger M, Burton BJL, Saada J, Cambell-Kelly M, Rushbrook S, Carding SR. A protocol paper for the MOTION Study-A longitudinal study in a cohort aged 60 years and older to obtain mechanistic knowledge of the role of the gut microbiome during normal healthy ageing in order to develop strategies that will improve lifelong health and wellbeing. PLoS One. 2022 Nov 18;17(11):e0276118. doi: 10.1371/journal.pone.0276118. eCollection 2022.

  PMID: 36399457 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool, blood and colon tissue biopsies.

Study Officials

• Simon R Carding, PhD

  Quadram Institute Bioscience

  STUDY CHAIR

• Simon M Rushbrook, MBBS

  Norfolk & Norwich University Hospital

  PRINCIPAL INVESTIGATOR

• Michael Hornberger, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

• Janak Saada, MBBS

  Norfolk & Norwich University Hospital

  PRINCIPAL INVESTIGATOR

• Ben Burton, FRC Opth

  James Paget Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available at the end of the study
• Access Criteria: Chief Investigator will review requests.

Locations

GB (1)