Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06708533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Gut Microbiome and Symptomology in IBS
Sponsor:
Nottingham Trent University
Organization:
Study Overview
Official Title:
Investigating the Gut Microbiome and Symptomology in IBS: Mechanisms and Therapeutic Implications for Symptom Relief Through Prescribed Physical Activity in Clinical Practice
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
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:
MICROFIT
Brief Summary:
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.
• 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:
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.
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.
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?:
False
Is an FDA AA801 Violation?: