Investigating the Gut Microbiome and Symptomology in IBS

NCT06708533 | Not Yet Recruiting

• 1 other identifier: 345554
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Physical Activity; Irritable Bowel Syndrome; Gut Microbiome; Exercise; IBS

Outcome Measures

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

  Baseline, Week 6, Week 12

Secondary Outcomes (7)

• Changes in Gut Microbiota Composition

  Baseline, Week 6, Week 12

• Changes in Metabolomic Profiles

  Baseline, Week 6, Week 12

• Changes in Proteome

  Baseline, Week 6, Week 12

• Physical Fitness Improvement

  Baseline, Week 6, Week 12

• Changes in Anxiety Levels

  Baseline, Week 6, Week 12

Study Arms (2)

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.

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.

Interventions

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.

12-week physical activity programme

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham Trent University: lead
• Nottingham University Hospitals NHS Trust: collaborator
• University of Reading: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hannah B Lindsell

CONTACT

+44 (0)115 848 5535; hannah.lindsell@ntu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11