Irritable Bowel Syndrome (IBS)Phase 4NCT01908465
Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial
A Phase 4 study testing Ebastine in people with Irritable Bowel Syndrome (IBS), run by KU Leuven at 12 sites in 2 countries.
Trial summary
Purpose: To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine. Design: Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Ebastine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Nov 2013to 2 Nov 2022
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
- age 18-65 years
Who cannot join
- IBS subtype with constipation
- medication: antidepressants or H1-receptor antagonists
- pregnancy, breast feeding
- co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Belgium6 sites
AZ Sint-Lucas Brugge
Bruges, West-Vlaanderen, 8310
UZ Antwerpen
Edegem, Antwerpen, 2650
ZOL (Ziekenhuis Oost-Limburg)
Genk, Limburg, 3600
UZ Gent
Ghent, Oost-Vlaanderen, 9000
UZ Leuven
Leuven, Vlaams-Brabant, 3000
AZ Sint-Elizabeth Zottegem
Zottegem, Oost-Vlaanderen, 9620
Netherlands6 sites
Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, 1061
Academisch Medisch Centrum
Amsterdam, North Holland, 1105
Rijnstate
Arnhem, Gelderland, 6800
Tergooiziekenuizen Blaricum/Hilversum
Blaricum, North Holland, 1213/1261
Medisch Spectrum Twente
Enschede, Limburg, 7500
AZ Maastricht
Maastricht, Limburg, 6202
About this study
Official title: Peripheral Histamine 1 Receptor Blockade in IBS
Purpose:
To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.
Design:
Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Ebastine, Placebo
- 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.
EbastineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ebastine | Active comparator | Ebastine Receives: Drug: Ebastine |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment on global symptom relief (of IBS complaints)
By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly "SGA (Subject's Global Assessment) of relief" and "SGA of Abdominal Pain and Discomfort" questionnaires
Measured: after 12 weeks treatment
Secondary outcomes (1)
Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
By mean of weekly questionnaires
Measured: fter 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startNov 2013
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
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 Syndrome (IBS)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Boeckxstaens, KU Leuven
- Investigators
- Guy Boeckxstaens, M.D., Principal investigator, Catholic University Leuven and Universitary Hospitals Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908465
- Sponsor's protocol ID
- S55485
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2013
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Decraecker L, De Looze D, Hirsch DP, De Schepper H, Arts J, Caenepeel P, Bredenoord AJ, Kolkman J, Bellens K, Van Beek K, Pia F, Peetermans W, Vanuytsel T, Denadai-Souza A, Belmans A, Boeckxstaens G. Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial. Gut. 2024 Feb 23;73(3):459-469. doi: 10.1136/gutjnl-2023-331634.
PubMed 38191268
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Histamine 1 Receptor Blockade in IBS
- ClinicalTrials.gov ID
- NCT01908465
- Acronym / sponsor ID
- S55485
- Conditions
- Irritable Bowel Syndrome (IBS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
Purpose:
To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.
Design:
Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ebastine | Active comparator | Drug: EbastineEbastine |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
- age 18-65 years
Key exclusion criteria (4 listed)
- IBS subtype with constipation
- medication: antidepressants or H1-receptor antagonists
- pregnancy, breast feeding
- co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
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 |
|---|---|---|
| Ebastine | Drug | Ebastine |
| Placebo | Drug | placebo |
Primary outcome
Effect of treatment on global symptom relief (of IBS complaints)
Time frame: after 12 weeks treatment
By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly "SGA (Subject's Global Assessment) of relief" and "SGA of Abdominal Pain and Discomfort" questionnaires
1 secondary outcome
Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
Time frame: fter 12 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38191268Decraecker L, De Looze D, Hirsch DP, De Schepper H, Arts J, Caenepeel P, Bredenoord AJ, Kolkman J, Bellens K, Van Beek K, Pia F, Peetermans W, Vanuytsel T, Denadai-Souza A, Belmans A, Boeckxstaens G. Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial. Gut. 2024 Feb 23;73(3):459-469. doi: 10.1136/gutjnl-2023-331634.
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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.
Guy Boeckxstaens, M.D. principal investigator
Catholic University Leuven and Universitary Hospitals Leuven
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ebastine in people with Irritable Bowel Syndrome (IBS), run by KU Leuven at 12 sites in 2 countries.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of treatment on global symptom relief (of IBS complaints) (time frame: after 12 weeks treatment). 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 NCT01908465, 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 8 Feb 2023.