Clinical trial NCT06708533: Investigating the Gut Microbiome and Symptomology in IBS
Official title: Investigating the Gut Microbiome and Symptomology in IBS: Mechanisms and Therapeutic Implications for Symptom Relief Through Prescribed Physical Activity in Clinical Practice
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Physical Activity
Irritable Bowel Syndrome
Gut Microbiome
Exercise
IBS
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: University of Reading
First posted: 2024-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Be 18-64 years old
* Have CLINCALLY DIAGNOSED IBS
* Know your IBS-SUBTYPE (e.g., constipation, diarrhoea, mixed/alternating)

Exclusion Criteria:

* Pregnant or breastfeeding
* 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

Primary outcomes:
measure: Clinically significant change in IBS Symptom Severity Score (IBS-SSS)
timeFrame: Baseline, Week 6, Week 12
Secondary outcomes:
measure: Changes in Gut Microbiota Composition
timeFrame: Baseline, Week 6, Week 12
measure: Changes in Metabolomic Profiles
timeFrame: Baseline, Week 6, Week 12
measure: Changes in Proteome
timeFrame: Baseline, Week 6, Week 12
measure: Physical Fitness Improvement
timeFrame: Baseline, Week 6, Week 12
measure: Changes in Anxiety Levels
timeFrame: Baseline, Week 6, Week 12
measure: Changes in Depression Levels
timeFrame: Baseline, Week 6, Week 12
measure: Change in Quality of Life (QoL) Scores
timeFrame: Baseline, Week 6, Week 12
Other outcomes:
Locations:
Study officials:
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