BridgeMD
New treatment option for Irritable Bowel Syndrome
Official title Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.
ClinicalTrials.gov ID: NCT05680766
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.