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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | - Control arm |
|
| Probiotic | Experimental | - Arm with active probiotic alone |
|
| Probiotic + Antispasmodic/Antifoam | Experimental | - Arm with active probiotic combined to antispasmodic/antifoam drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I31 probiotic | Dietary 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuria Lopez Perez, MD | Hospital Juarez de Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juarez de Mexico | Mexico City | Mexico City | 07760 | Mexico |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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| I31 probiotic combined to Alverine/Simethicone | Combination Product |
|
|
| Placebo | Other | Placebo treatment (maltodextrin), once daily (u.i.d) |
|
| 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. |
| 6 weeks |
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |