Irritable Bowel SyndromeCASCADENCT05097872
ConfocAl endomicroSCopy bAsed Diet Trial in IBS
A study testing Diet in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
After a thorough baseline evaluation, IBS patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2021to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 y/o (70 years included)
- Male or female subjects
- IBS-D and IBS-M (i.e. IBS-non-C) according to Rome IV criteria
- Moderate to severe symptom severity as defined by the Irritable bowel syndrome severity scoring system (IBS-SSS) (i.e. IBS-SSS >175 points)
- Provide written informed consent to participate in the study
- Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
Who cannot join
- - Pregnant or breastfeeding women
- History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
- Symptoms predominantly associated with functional dyspepsia or gastro-esophageal reflux disease
- Immunoglobuline E (IgE)-mediated food allergies identified by immunocap blood tests or skin prick testing
- Known underlying organic gastrointestinal disease
- Current or recent use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks.
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- Allergy to Fluorescein, Xylocaine or Propofol
- Known celiac disease
- Following a diet interfering with the study diet in opinion of the investigator
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Lukas M Balsiger, MD, +32492447624, lukasmichaja.balsiger@kuleuven.be
About this study
Official title: Targeted Elimination Diet in IBS Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
After a thorough baseline evaluation, IBS patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet
- 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.
DietOther
Diet excluding either trigger and sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger)
| Study group | Role | What they receive |
|---|---|---|
| Real diet | Active comparator | Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE Receives: Other: Diet |
| Sham diet | Sham comparator | Diet excluding a sham nutrient without acute mucosal reaction in CLE Receives: Other: Diet |
| Wheat exclusion diet | Active comparator | In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. Receives: Other: Diet |
| Soy exclusion diet | Active comparator | In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rates in targeted diet vs sham diet
Response defined by an improvement of minimum 50 points in the IBS-SSS.
Measured: After 4 weeks of dietary intervention
Secondary outcomes (3)
Baseline permeability measures between groups
Differences in baseline permeability measures between CLE positive and negative patients and healthy volunteers using Ussing chambers
Measured: At baseline
Evolution of permeability measures between dietary interventions
Differences in permeability measures between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Measured: Baseline and end of respective dietary intervention
Baseline mucosal immune cell composition between groups
Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start19 Oct 2021
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097872
- Sponsor's protocol ID
- S65495
- Acronym
- CASCADE
- Status last verified
- Jul 2024
- First submitted
- 15 Oct 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balsiger LM, Schol J, Raymenants K, Van de Bruaene C, Toth J, Routhiaux K, Ceulemans M, Vanderstappen J, Verbiest A, Jones M, Farre R, Vanuytsel T, Tack J. Individualized targeted exclusion diet based on confocal laser endomicroscopy does not improve irritable bowel syndrome symptoms: a randomized controlled crossover trial. Gastroenterology. 2026 Sep 1:S0016-5085(26)07228-8. doi: 10.1053/j.gastro.2026.08.026. Online ahead of print.
PubMed 42680074
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Elimination Diet in IBS Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT05097872
- Acronym / sponsor ID
- CASCADE / S65495
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Oct 2021 (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.
After a thorough baseline evaluation, IBS patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Real diet | Active comparator | Other: DietDiet excluding the trigger nutrient identified by an acute mucosal reaction in CLE |
| Sham diet | Sham comparator | Other: DietDiet excluding a sham nutrient without acute mucosal reaction in CLE |
| Wheat exclusion diet | Active comparator | Other: DietIn patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. |
| Soy exclusion diet | Active comparator | Other: DietIn patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 y/o (70 years included)
- Male or female subjects
- IBS-D and IBS-M (i.e. IBS-non-C) according to Rome IV criteria
- Moderate to severe symptom severity as defined by the Irritable bowel syndrome severity scoring system (IBS-SSS) (i.e. IBS-SSS >175 points)
- Provide written informed consent to participate in the study
Key exclusion criteria (9 listed)
- - Pregnant or breastfeeding women
- History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
- Symptoms predominantly associated with functional dyspepsia or gastro-esophageal reflux disease
- Immunoglobuline E (IgE)-mediated food allergies identified by immunocap blood tests or skin prick testing
- Known underlying organic gastrointestinal disease
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 |
|---|---|---|
| DietDiet excluding either trigger and sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger) | Other | Real diet, Sham diet, Soy exclusion diet, Wheat exclusion diet |
Primary outcome
Responder rates in targeted diet vs sham diet
Time frame: After 4 weeks of dietary intervention
Response defined by an improvement of minimum 50 points in the IBS-SSS.
3 secondary outcomes
Baseline permeability measures between groups
Time frame: At baseline
Evolution of permeability measures between dietary interventions
Time frame: Baseline and end of respective dietary intervention
Baseline mucosal immune cell composition between groups
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 42680074Balsiger LM, Schol J, Raymenants K, Van de Bruaene C, Toth J, Routhiaux K, Ceulemans M, Vanderstappen J, Verbiest A, Jones M, Farre R, Vanuytsel T, Tack J. Individualized targeted exclusion diet based on confocal laser endomicroscopy does not improve irritable bowel syndrome symptoms: a randomized controlled crossover trial. Gastroenterology. 2026 Sep 1:S0016-5085(26)07228-8. doi: 10.1053/j.gastro.2026.08.026. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukas M Balsiger, MD (+32 16 37 70 90, lukasmichaja.balsiger@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rates in targeted diet vs sham diet (time frame: After 4 weeks of dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097872, which also lists 1 linked publication.
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 3 Jul 2024.