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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05680766
Other study ID # Face-IT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2023
Est. completion date January 2, 2027

Study information

Verified date June 2024
Source Universitair Ziekenhuis Brussel
Contact Sébastien Kindt
Phone +32 2 477
Email sebastien.kindt@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes. These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option. Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 2, 2027
Est. primary completion date January 2, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients aged 18 - 60 years; - Fulfilling the ROME IV criteria for Irritable bowel syndrome (IBS); - Moderate symptom severity as defined by a IBS-Symptom Severity Scale > 175; - Sedentary lifestyle defined as SIT-Q-7D > 8h/day; - Physically inactive defined as < 150min/week on the IPAQ score Exclusion Criteria: - Cardiorespiratory disorder hampering participation in a program of physical exercise as evidenced by the sport + keuringsartsen (SKA) questionnaire. - Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded); - Known inflammatory bowel disorder; - Known intestinal motility disorder; - Alcohol (defined as more than 14 U per week) or other substance abuse; - Active psychiatric disorder; - Known systemic or auto-immune disorder with implication for the GI system; - Prior abdominal surgery (with the exception of appendectomy or cholecystectomy more than 6 months ago); - Any prior diagnosis of cancer other than basocellular carcinoma; - Current chemotherapy; - History of gastro-enteritis in the past 8 weeks; - Change in diet in the past 8 weeks; - Dietary supplements unless taken at a stable dose for more than 8 weeks; - Antibiotics, pre-, pro-, post-biotics or any combination during the past 8 weeks; - Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed); - Treatment with spasmolytic agents, opioids, loperamide, gelatine tannate or mucoprotect-ants during the past 8 weeks.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cardiovascular endurance training
Based on the results of a maximal effort test, investigators will provide a personalised training program. Results of a submaximal effort test after 6 weeks, will allow for adaptation of the training program for the remaining training period.

Locations

Country Name City State
Belgium UZ Brussel Jette

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of IBS Symptom severity this will be assessed after patients have done a cardiovascular endurance training from baseline to 12 weeks
Secondary Change of IBS Symptom severity this will be assessed after patients have done a cardiovascular endurance training from baseline to 6 weeks
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