Irritable Bowel SyndromeNCT05680766
Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.
A study testing Cardiovascular endurance training in people with Irritable Bowel Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Cardiovascular endurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2023to 2 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, 1090
Sebastien Kindt, +32 2 477 ext. 60 11
About this study
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Cardiovascular endurance training
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular endurance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET). Receives: Other: Cardiovascular endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IBS Symptom severity
this will be assessed after patients have done a cardiovascular endurance training
Measured: from baseline to 12 weeks
Secondary outcomes (1)
Change of IBS Symptom severity
this will be assessed after patients have done a cardiovascular endurance training
Measured: from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start16 Oct 2023
- Primary completion2 Jan 2030 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680766
- Sponsor's protocol ID
- Face-IT
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- Face-IT
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 2 Jan 2030 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Cardiovascular endurance trainingIBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular endurance trainingBased 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. | Other | Intervention arm |
Primary outcome
Change of IBS Symptom severity
Time frame: from baseline to 12 weeks
this will be assessed after patients have done a cardiovascular endurance training
1 secondary outcome
Change of IBS Symptom severity
Time frame: from baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular endurance training in people with Irritable Bowel Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Kindt (+32 2 477 ext. 60 11, sebastien.kindt@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of IBS Symptom severity (time frame: from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.