Investigating the Gut Microbiome and Symptomology in IBS
NCT ID: NCT06708533
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-03-31
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• Primary Outcome: Does engaging in routine physical activity reduce the severity of IBS symptoms compared to baseline levels?
Comparison Group: Researchers will compare the intervention group (receiving the 12-week physical activity program) with a control group (receiving no intervention for 12-weeks).
Participant Activities and Interventions:
* Complete a 12-week walking programme.
* Visit the university on 3 occasions (baseline, week-6 and week-12) for biological sample collection and sub-maximal fitness assessments.
* Complete a series of subjective health related questionnaires.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants are assigned to either the intervention group, where they will engage in routine walking sessions, or to a control group, which will not participate in the physical activity program. The primary outcome is the reduction in IBS symptom severity compared to baseline, with secondary outcomes including quality of life (QoL) scores, anxiety, and depression levels in addition to biological markers.
Study activities include:
* Walking Program: Participants in the intervention group will follow a personalised moderate-intensity walking program, with frequency and duration tailored to meet a 12-week schedule and personalised to individual 6-minute walk test results.
* University Visits: All participants will attend three university visits at baseline, week 6, and week 12. During these visits, biological samples will be collected for the assessment of gut microbiome, metabolome, proteome, and sub-maximal fitness assessments (6-minute walk test and hand grip strength) will be conducted.
* Questionnaires: Participants will complete validated questionnaires assessing IBS symptoms, quality of life, and psychological well-being (including anxiety and depression) at each visit to track any changes over time.
The study aims to provide insights into the potential benefits of physical activity as a non-pharmacological management strategy for IBS management.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
12-week physical activity programme
Participants in this arm will engage in a structured 12-week walking program. They will complete sub-maximal fitness assessments and provide biological samples during visits to the university at baseline, week 6, and week 12. They will also complete questionnaires assessing IBS symptoms, quality of life (QoL), anxiety, depression, and other factors.
Physical Activity
This intervention involves a structured 12-week walking program designed to increase routine physical activity among participants diagnosed with IBS. The intervention focuses on moderate-intensity walking, performed regularly, in line with World Health Organisation (WHO) guidelines with the aim of relieving IBS symptoms.
Key elements include:
Participants will be guided to adhere to an individualised walking protocol, ensuring consistency in activity levels.
Physical activity levels will be monitored using self-reported diaries and wearable activity trackers to ensure compliance.
Participants will also attend three scheduled visits to the university (baseline, week 6, and week 12) for biological sample collection, sub-maximal fitness assessments, and the completion of validated questionnaires on IBS symptoms, quality of life (QoL), anxiety, and depression.
No intervention control group
Participants in this arm will not receive any intervention and will continue their usual lifestyle for the study duration. They will complete the same assessments as the intervention arm, including providing biological samples, undergoing sub-maximal fitness tests, and completing questionnaires at baseline, week 6, and week 12. This arm serves as a comparison group to evaluate the effects of the walking program.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Physical Activity
This intervention involves a structured 12-week walking program designed to increase routine physical activity among participants diagnosed with IBS. The intervention focuses on moderate-intensity walking, performed regularly, in line with World Health Organisation (WHO) guidelines with the aim of relieving IBS symptoms.
Key elements include:
Participants will be guided to adhere to an individualised walking protocol, ensuring consistency in activity levels.
Physical activity levels will be monitored using self-reported diaries and wearable activity trackers to ensure compliance.
Participants will also attend three scheduled visits to the university (baseline, week 6, and week 12) for biological sample collection, sub-maximal fitness assessments, and the completion of validated questionnaires on IBS symptoms, quality of life (QoL), anxiety, and depression.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have CLINCALLY DIAGNOSED IBS
* Know your IBS-SUBTYPE (e.g., constipation, diarrhoea, mixed/alternating)
Exclusion Criteria
* Organic gastrointestinal conditions (Inflammatory Bowel Disease, Coeliac Disease, Colorectal Cancer)
* On medication with known influence on gastrointestinal motility (thyroid disease, diabetes mellitus, coeliac disease and neurological disease)
* Have used antibiotics in the past 3 months
* Currently using opioid pain medications (except occasional/non-daily use of NSAIDs)
* Regular consumption of pre- and probiotic foods/supplements
* Completing more than 300-minutes of PA per week
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nottingham University Hospitals NHS Trust
OTHER
University of Reading
OTHER
Nottingham Trent University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hannah Lindsell
Ms
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
345554
Identifier Type: -
Identifier Source: org_study_id