Irritable Bowel SyndromePhase 4NCT04145856
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
A Phase 4 study testing I31 probiotic and I31 probiotic combined to Alverine/Simethicone in people with Irritable Bowel Syndrome, run by Hospital Juarez de Mexico at 1 site in Mexico.
Trial summary
This randomized study evaluates the usefulness of the I31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- I31 probiotic and I31 probiotic combined to Alverine/Simethicone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteMexico
- Study dates
- 3 Sep 2018to 27 Aug 2019
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects attending Hospital Juarez de Mexico with a diagnosis of diarrhea-predominant or mixed irritable bowel syndrome (IBS-D and IBS-M), according to Rome-IV criteria (Lacy et al. Gastroenterology 2016), providing Informed Consent.
Who cannot join
- Unexplained weight loss, blood in feces, anemia.
- Use of systemic antibiotics, NSAIDs, antipsychotic or prokinetic medication in the 3 weeks before study initiation.
- Pregnant or lactating women.
- History of gastrointestinal cancer.
- Suspicion of coeliac disease, inflammatory bowel disease (IBD), endometriosis or pelvic inflammatory disease.
- History of abdominal surgery within 2 years (3 months if appendectomy or herniorraphy)
- BMI below 18
- Known allergy to any of the components in the treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Combination Therapy With Alverine-simeticone and i3.1 Probiotic Formula in the Quality of Life of Patients With IBS-D or IBS-M in Hospital Juarez Mexico
This randomized study evaluates the usefulness of the I31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome
Read the detailed description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention.
I31 is a probiotic formula composed of strains Pediococcus acidilactici CECT7483 and Lactobacillus plantarum CECT7484 and CECT7485, previously shown to improve quality of life in patients with IBS of Caucasian descent.
Alverine/simethicone is a combination of two drugs: Alverine citrate relaxes muscle cramps that occur in the intestine in conditions such as irritable bowel syndrome and diverticulosis. Simethicone is an antifoam administered orally. Reduces gas formation and facilitates its elimination from the digestive tract
- Conditions
- Irritable Bowel Syndrome
- Being tested
- I31 probiotic, I31 probiotic combined to Alverine/Simethicone, Placebo
- Keywords
- Probiotic, Antispasmodic, Rome-IV
- 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.
I31 probioticDietary supplement
I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
I31 probiotic combined to Alverine/SimethiconeCombination product
- I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
- Antispasmodic/antifoam drug, consisting of Alverine Citrate 60 mg and Simethicone 300 mg, thrice daily (t.i.d)
PlaceboOther
Placebo treatment (maltodextrin), once daily (u.i.d)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | - Control arm Receives: Other: Placebo |
| Probiotic | Experimental | - Arm with active probiotic alone Receives: Dietary Supplement: I31 probiotic |
| Probiotic + Antispasmodic/Antifoam | Experimental | - Arm with active probiotic combined to antispasmodic/antifoam drug Receives: Combination Product: I31 probiotic combined to Alverine/Simethicone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific quality of life (QoL)
Irritable bowel syndrome-specific validated IBSQoL questionnaire (Hahn et al. Aliment Pharmacol Ther 1997). Response is defined as an improvement of 15 or more points in the normalized 0-100 score
Measured: 6 weeks
Secondary outcomes (2)
Abdominal Pain
Abdominal Pain Visual Analog Scale, ranging 0 to 10 (i.e. 11-point scale, as recommended by FDA, May 2012 Guidance on Irritable Bowel Syndrome - Clinical Evaluation of Products for Treatment). Response is defined as an improvement of 30% at the end of the intervention compared to baseline.
Measured: 6 weeks
Diarrhea
Stool consistency as determined with the Bristol scale (Lewis \& Heaton, Scand. J. Gastroenterol 1997). Response is defined as a score equal or below 5 at the end of the intervention.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start3 Sep 2018
- Primary completion2 May 2019
- Study completion27 Aug 2019
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nuria Pérez López, Hospital Juarez de Mexico
- Investigators
- Nuria Lopez Perez, MD, Study director, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145856
- Sponsor's protocol ID
- HJM 0492/18-R
- Status last verified
- Jan 2020
- First submitted
- 29 Oct 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Combination Therapy With Alverine-simeticone and i3.1 Probiotic Formula in the Quality of Life of Patients With IBS-D or IBS-M in Hospital Juarez Mexico
- ClinicalTrials.gov ID
- NCT04145856
- Acronym / sponsor ID
- HJM 0492/18-R
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Probiotic, Antispasmodic, Rome-IV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 31 Oct 2019 (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 randomized study evaluates the usefulness of the I31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome
Detailed description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention.
I31 is a probiotic formula composed of strains Pediococcus acidilactici CECT7483 and Lactobacillus plantarum CECT7484 and CECT7485, previously shown to improve quality of life in patients with IBS of Caucasian descent.
Alverine/simethicone is a combination of two drugs: Alverine citrate relaxes muscle cramps that occur in the intestine in conditions such as irritable bowel syndrome and diverticulosis. Simethicone is an antifoam administered orally. Reduces gas formation and facilitates its elimination from the digestive tract
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo- Control arm |
| Probiotic | Experimental | Dietary Supplement: I31 probiotic- Arm with active probiotic alone |
| Probiotic + Antispasmodic/Antifoam | Experimental | Combination Product: I31 probiotic combined to Alverine/Simethicone- Arm with active probiotic combined to antispasmodic/antifoam drug |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects attending Hospital Juarez de Mexico with a diagnosis of diarrhea-predominant or mixed irritable bowel syndrome (IBS-D and IBS-M), according to Rome-IV criteria (Lacy et al. Gastroenterology 2016), providing Informed Consent.
Key exclusion criteria (8 listed)
- Unexplained weight loss, blood in feces, anemia.
- Use of systemic antibiotics, NSAIDs, antipsychotic or prokinetic medication in the 3 weeks before study initiation.
- Pregnant or lactating women.
- History of gastrointestinal cancer.
- Suspicion of coeliac disease, inflammatory bowel disease (IBD), endometriosis or pelvic inflammatory 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 |
|---|---|---|
| I31 probioticI31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d) | Dietary supplement | Probiotic |
| I31 probiotic combined to Alverine/Simethicone* I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d) * Antispasmodic/antifoam drug, consisting of Alverine Citrate 60 mg and Simethicone 300 mg, thrice daily (t.i.d) | Combination product | Probiotic + Antispasmodic/Antifoam |
| PlaceboPlacebo treatment (maltodextrin), once daily (u.i.d) | Other | Placebo |
Primary outcome
Disease-specific quality of life (QoL)
Time frame: 6 weeks
Irritable bowel syndrome-specific validated IBSQoL questionnaire (Hahn et al. Aliment Pharmacol Ther 1997). Response is defined as an improvement of 15 or more points in the normalized 0-100 score
2 secondary outcomes
Abdominal Pain
Time frame: 6 weeks
Diarrhea
Time frame: 6 weeks
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 23 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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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.
Nuria Lopez Perez, MD study director
Hospital Juarez de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing I31 probiotic and I31 probiotic combined to Alverine/Simethicone in people with Irritable Bowel Syndrome, run by Hospital Juarez de Mexico at 1 site in Mexico.
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 8 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 23 Jan 2020. 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 Mexico. 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?
Disease-specific quality of life (QoL) (time frame: 6 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 23 Jan 2020.