Feasibility of Using Surplus qFIT Samples to Investigate the Gut Microbiota.

NCT06100549 | Completed

• 1 other identifier: 502
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The Scottish Bowel Screening Programme is an enormous potential research resource; half a million people in Scotland do their bowel screening test each year. If we could obtain meaningful data on the gut microbiota in these individuals, many clinical questions could be answered using nested case-control studies relating gut microbiota profiles to cancer, obesity, cardiovascular and metabolic diseases and Alzheimer's disease. As individuals are screened from age 50 to 74 years, there would also be excellent opportunities for longer-term longitudinal studies. Since 2017, the bowel screening programme has used qFIT testing for faecal haemoglobin. Patients collect a tiny (2 miligram) sample of their faeces into 2 mililiter of buffer but only approximately 6 microliter is required for testing. The goal of this study is to investigate whether the large number of patients' samples available from the National Bowel Screening Programme could be used in future gut microbiome studies using the leftover faeces in buffer in the qFIT tests.

Conditions

Gut Microbiota

Keywords

qFIT; Bowel Screening Programme; Gut microbiome

Outcome Measures

Primary Outcomes (1)

• Microbial composition using 16S sequencing.

  Comparison of 16S rRNA gene sequencing of fresh faeces processed within 24 hours from 16 human volunteers using qFIT collection cassettes and conventional faecal collection methods.

  5 months

Secondary Outcomes (2)

• DNA yield over time, quantified by Qubit

  6 months

• Comparison DNA yield from 16 volunteers with NHS setting

  10 months

Study Arms (2)

16 Healthy people

The volunteers will be healthy men and women aged 18 to 65 with a BMI between 18.5 and 30 kg/m2. Volunteers will provide a single stool sample to compare 16S rRNA gene sequencing results for gut microbiota between faeces processed from standard stool sample and those collected by the collection device (EXTEL HEMO AUTO MC Collection Picker) used in the Scottish Bowel Screening Programme.

Other: No intervention

100 anonymised qFIT samples

To determine whether our carefully controlled conditions are replicated in the NHS setting, one hundred anonymised qFIT samples will be obtained from Chemical Pathology Aberdeen Royal Infirmary under NHS Grampian Biorepository ethical approval. Extracted DNA will be quantified by Qubit and run on an agarose gel to determine the intact nature of the DNA.

Other: No intervention

Interventions

No intervention OTHER

No intervention will be provided.

100 anonymised qFIT samples; 16 Healthy people

Eligibility Criteria

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

Study Population

Healthy people between 18 and 65 years old.

You may qualify if:

• Healthy men and women
• Aged 18 to 65
• BMI 18.5 and 30 kg/m2

You may not qualify if:

• A member of Prof Kiltie's lab
• Cconsumed antibiotics within the last 3 months
• Pregnant or breastfeeding
• Cannot drop your samples off at the Rowett Institute
• Have any of the following: History of cardiovascular disease/stroke, diabetes, gastrointestinal disease, autoimmune disorders or cancer.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Publications (2)

• Baxter NT, Koumpouras CC, Rogers MA, Ruffin MT 4th, Schloss PD. DNA from fecal immunochemical test can replace stool for detection of colonic lesions using a microbiota-based model. Microbiome. 2016 Nov 14;4(1):59. doi: 10.1186/s40168-016-0205-y.

  PMID: 27842559 BACKGROUND

• Vogtmann E, Chen J, Amir A, Shi J, Abnet CC, Nelson H, Knight R, Chia N, Sinha R. Comparison of Collection Methods for Fecal Samples in Microbiome Studies. Am J Epidemiol. 2017 Jan 15;185(2):115-123. doi: 10.1093/aje/kww177. Epub 2016 Dec 16.

  PMID: 27986704 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Faecal sample with gut microbiota DNA

Study Officials

• Anne E Kiltie, Prof

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: November 28, 2023
• Primary Completion: February 12, 2024
• Study Completion: September 30, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)