Investigating the Gut Microbiome and Symptomology in IBS

Официальное название

Investigating the Gut Microbiome and Symptomology in IBS: Mechanisms and Therapeutic Implications for Symptom Relief Through Prescribed Physical Activity in Clinical Practice

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Physical Activity
  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 m

Первичные конечные точки

• Clinically significant change in IBS Symptom Severity Score (IBS-SSS) [Срок оценки: Baseline, Week 6, Week 12]

Вторичные конечные точки (7)

• Changes in Gut Microbiota Composition [Срок оценки: Baseline, Week 6, Week 12]
• Changes in Metabolomic Profiles [Срок оценки: Baseline, Week 6, Week 12]
• Changes in Proteome [Срок оценки: Baseline, Week 6, Week 12]
• Physical Fitness Improvement [Срок оценки: Baseline, Week 6, Week 12]
• Changes in Anxiety Levels [Срок оценки: Baseline, Week 6, Week 12]
• Changes in Depression Levels [Срок оценки: Baseline, Week 6, Week 12]
• Change in Quality of Life (QoL) Scores [Срок оценки: Baseline, Week 6, Week 12]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06708533 · 345554

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗