Irritable Bowel SyndromePhase 2/3NCT03359499
Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients
A Phase 2/3 study testing Bacillus clausii and Trimebutine in people with Irritable Bowel Syndrome, run by Hospital Britanico at 1 site in Argentina.
Trial summary
Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bacillus clausii and Trimebutine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArgentina
- Study dates
- 12 Aug 2017to 23 Nov 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria
Who cannot join
- Allergy to Bacillus clausii spores
- Prior treatment with antibiotics or probiotics (4 weeks)
- Not willing to fulfill symptom diary
- Pregnancy or breastfeeding
- Clinical suspicion of organic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study
Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bacillus clausii, Trimebutine
- 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.
Bacillus clausiiDrug
Also called Dietary advice
Oral suspension administered BID
TrimebutineDrug
One tablet of 200 mg of trimebutine administered BID
| Study group | Role | What they receive |
|---|---|---|
| Bacillus clausii | Experimental | Bacillus clausii administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome Receives: Drug: Bacillus clausii |
| Antispasmodic | Other | Trimebutine administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome Receives: Drug: Trimebutine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic response
Decrease of at least 50% of symptom severity score - The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500. Based on previously published studies, clinical response will be defined as a decrease in at least 50% of the initial score
Measured: After two weeks of treatment
Secondary outcomes (1)
Symptomatic relapse
An increase of at least 30% in the symptomatic score based on daily follow up. The score that will be used is the The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500.
Measured: Four weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start12 Aug 2017
- Primary completion25 Oct 2017
- Study completion23 Nov 2017
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Britanico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Sebastian Lasa, Hospital Britanico
- Investigators
- Juan S Lasa, MD, Principal investigator, Hospital Britanico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359499
- Sponsor's protocol ID
- HB744
- Status last verified
- Mar 2018
- First submitted
- 25 Nov 2017
- Last updated
- 13 Mar 2018
- 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 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT03359499
- Acronym / sponsor ID
- HB744
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital BritanicoUniversity, hospital or other
- Study start
- 12 Aug 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 2 Dec 2017 (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.
Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus clausii | Experimental | Drug: Bacillus clausiiBacillus clausii administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome |
| Antispasmodic | Other | Drug: TrimebutineTrimebutine administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria
Key exclusion criteria (5 listed)
- Allergy to Bacillus clausii spores
- Prior treatment with antibiotics or probiotics (4 weeks)
- Not willing to fulfill symptom diary
- Pregnancy or breastfeeding
- Clinical suspicion of organic 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 |
|---|---|---|
| Bacillus clausiiAlso: Dietary adviceOral suspension administered BID | Drug | Bacillus clausii |
| TrimebutineOne tablet of 200 mg of trimebutine administered BID | Drug | Antispasmodic |
Primary outcome
Symptomatic response
Time frame: After two weeks of treatment
Decrease of at least 50% of symptom severity score - The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500. Based on previously published studies, clinical response will be defined as a decrease in at least 50% of the initial score
1 secondary outcome
Symptomatic relapse
Time frame: Four weeks after treatment completion
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 13 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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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. This study is not recruiting at the moment.
Juan S Lasa, MD principal investigator
Hospital Britanico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bacillus clausii and Trimebutine in people with Irritable Bowel Syndrome, run by Hospital Britanico at 1 site in Argentina.
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 1 inclusion and 5 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 13 Mar 2018. 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 Argentina. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Symptomatic response (time frame: After two weeks of treatment). 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 13 Mar 2018.