Investigating the Gut Microbiome and Symptomology in IBS (MICROFIT)

Nottingham Trent University

Status: Not yet enrolling

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06708533

345554

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

12-week physical activity programme

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity

No intervention control group

No Intervention group

Description:

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.