Health TrialsbyHealthPanel

Investigating the Gut Microbiome and Symptomology in IBS

ConditionIrritable Bowel Syndrome (IBS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNottingham Trent University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be 18-64 years old

Have CLINCALLY DIAGNOSED IBS

Know your IBS-SUBTYPE (e.g., constipation, diarrhoea, mixed/alternating)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical Activity

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: 12-week physical activity programmeExperimental treatment 1 intervention
Group B: No intervention control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Week 6, Week 12

Secondary outcomes

1

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).

Time frame
Baseline, Week 6, Week 12
2

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.

Time frame
Baseline, Week 6, Week 12
3

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.

Time frame
Baseline, Week 6, Week 12
4

Physical Fitness Improvement

Sub-maximal fitness tests will assess changes in participants' aerobic capacity as an indicator of physical activity levels.

Time frame
Baseline, Week 6, Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nottingham Trent University

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

University of Reading

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: