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Investigating the Gut Microbiome and Symptomology in IBS: Mechanisms and Therapeutic Implications for Symptom Relief Through Prescribed Physical Activity in Clinical Practice
This intervention study explores whether a routine physical activity intervention can help manage or relieve symptoms of Irritable Bowel Syndrome (IBS) in adults who have been clinically diagnosed with IBS. The main questions it aims to answer is: • 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.
This study investigates the effects of a structured routine physical activity intervention on symptom management in adults with irritable bowel syndrome (IBS). The intervention consists of a 12-week walking program designed to assess whether regular physical activity can reduce IBS symptom severity and improve quality of life. 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.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2025
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
November 27, 2024
40
ESTIMATED participants
Physical Activity
BEHAVIORAL
Lead Sponsor
Nottingham Trent University
Collaborators
NCT07481422
NCT06657001
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02092402