Irritable Bowel Syndrome (IBS)MICROFITNCT06708533
Investigating the Gut Microbiome and Symptomology in IBS
A study testing Physical Activity in people with Irritable Bowel Syndrome (IBS), run by Nottingham Trent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be 18-64 years old
- Have CLINCALLY DIAGNOSED IBS
- Know your IBS-SUBTYPE (e.g., constipation, diarrhoea, mixed/alternating)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Physical Activity
- Keywords
- Physical Activity, Irritable Bowel Syndrome, Gut Microbiome, Exercise, IBS
- Medical subject headings
- Irritable Bowel Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 12-week physical activity programme | Experimental | 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. Receives: Behavioral: Physical Activity |
| No intervention control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant change in IBS Symptom Severity Score (IBS-SSS)
The primary outcome will assess changes in IBS symptom severity over the 12-week intervention using a validated measure such as the IBS Severity Scoring System (IBS-SSS). This includes self-reported symptom scores for pain, frequency of bowel disturbances, and overall impact on daily life.
A scale of 0-500, with higher scores indicative of more severe symtpoms and a change in 50points indicates a clinically significant change.
The categories:
Healthy: 0-74 Mild IBS: 75 ≤ Score < 175 Moderate IBS: 175 ≤ Score < 300 Severe IBS: Score ≥ 300
Measured: Baseline, Week 6, Week 12
Secondary outcomes (7)
Changes in Gut Microbiota Composition
Biological samples (e.g., stool) will be analysed to assess changes in gut microbiota composition. This aims to elucidate potential mechanisms underlying symptom relief associated with the intervention. Specific analyses will include:
- Characterisation of microbial diversity and abundance using next-generation sequencing (e.g., 16S rRNA sequencing).
Measured: Baseline, Week 6, Week 12
Changes in Metabolomic Profiles
Biological samples (e.g., blood) will be analysed to assess changes in metabolomic profile. This aims to elucidate potential mechanisms underlying symptom relief associated with the intervention. Specific analyses will include:
- Identification of key metabolites and pathways involved through untargeted metabolomics.
Measured: Baseline, Week 6, Week 12
Changes in Proteome
Biological samples (e.g., blood) will be analysed to assess changes in gut proteome profile. This aims to elucidate potential mechanisms underlying symptom relief associated with the intervention. Specific analyses will include:
- Proteomic analysis to explore systemic changes and molecular signatures linked to IBS symptom modulation.
Measured: Baseline, Week 6, Week 12
Physical Fitness Improvement
Sub-maximal fitness tests will assess changes in participants' aerobic capacity as an indicator of physical activity levels.
Measured: Baseline, Week 6, Week 12
Changes in Anxiety Levels
Evaluated using the Generalized Anxiety Disorder-7 (GAD-7) self report questionnaires.
Participants rate how often they've experienced seven symptoms over the past two weeks, with each item scored from 0 ("Not at all") to 3 ("Nearly every day").
The total score is calculated by summing the responses, with a maximum score of 21. Higher scores indicate greater anxiety severity, categorised as follows:
None: 0-4 Mild: 5-9 Moderate: 10-14 Severe: 15-21
Measured: Baseline, Week 6, Week 12
Changes in Depression Levels
Evaluated using the Patient Health Questionnaire-8 (PHQ-8) self report questionnaires.
Participants rate how often they've experienced eight symptoms over the past two weeks, with each item scored from 0 ("Not at all") to 3 ("Nearly every day").
The total score is the sum of responses, with a maximum score of 24. Higher scores indicate greater depression severity, categorised as follows:
None: 0-4 Mild: 5-9 Moderate: 10-14 Moderately Severe: 15-19 Severe: 20-24
Measured: Baseline, Week 6, Week 12
Change in Quality of Life (QoL) Scores
Assessed using a validated Short Form Health Survey (SF-36), QoL questionnaire.
The SF-36 is a health survey assessing quality of life across 9 domains:
Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Health, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain, General Health, and Health Change.
Each domain is scored from 0 to 100, with higher scores indicating better health.
Measured: Baseline, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study startMar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University of Reading
- Responsible party
- Principal investigator, Hannah Lindsell, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708533
- Sponsor's protocol ID
- 345554
- Acronym
- MICROFIT
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Gut Microbiome and Symptomology in IBS: Mechanisms and Therapeutic Implications for Symptom Relief Through Prescribed Physical Activity in Clinical Practice
- ClinicalTrials.gov ID
- NCT06708533
- Acronym / sponsor ID
- MICROFIT / 345554
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Physical Activity, Irritable Bowel Syndrome, Gut Microbiome, Exercise, IBS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University of Reading
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week physical activity programme | Experimental | Behavioral: Physical ActivityParticipants 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. |
| No intervention control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be 18-64 years old
- Have CLINCALLY DIAGNOSED IBS
- Know your IBS-SUBTYPE (e.g., constipation, diarrhoea, mixed/alternating)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityThis 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. | Behavioural | 12-week physical activity programme |
Primary outcome
Clinically significant change in IBS Symptom Severity Score (IBS-SSS)
Time frame: Baseline, Week 6, Week 12
The primary outcome will assess changes in IBS symptom severity over the 12-week intervention using a validated measure such as the IBS Severity Scoring System (IBS-SSS). This includes self-reported symptom scores for pain, frequency of bowel disturbances, and overall impact on daily life. A scale of 0-500, with higher scores indicative of more severe symtpoms and a change in 50points indicates a clinically significant change. The categories: Healthy: 0-74 Mild IBS: 75 ≤ Score < 175 Moderate IBS: 175 ≤ Score < 300 Severe IBS: Score ≥ 300
7 secondary outcomes
Changes in Gut Microbiota Composition
Time frame: Baseline, Week 6, Week 12
Changes in Metabolomic Profiles
Time frame: Baseline, Week 6, Week 12
Changes in Proteome
Time frame: Baseline, Week 6, Week 12
Physical Fitness Improvement
Time frame: Baseline, Week 6, Week 12
Changes in Anxiety Levels
Time frame: Baseline, Week 6, Week 12
Changes in Depression Levels
Time frame: Baseline, Week 6, Week 12
Change in Quality of Life (QoL) Scores
Time frame: Baseline, Week 6, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Irritable Bowel Syndrome (IBS), run by Nottingham Trent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah B Lindsell (+44 (0)115 848 5535, hannah.lindsell@ntu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant change in IBS Symptom Severity Score (IBS-SSS) (time frame: Baseline, Week 6, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.