Irritable bowel syndrome
Conditions
Interventions
Stage 1:
Group I (Experimental) - Colilen IBS (Batch A): 2 capsules of 587 mg by oral route, three times a day, between 30 minutes and 2 hours before meals, for 12 weeks.
Group II (Control)- Placebo
Equipment and Supplies
Administration, Oral
Placebos
Colilen,
Medical device,
Cytoprotective
Sponsors
Aboca SpA Società Agricola laboratories
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patient aged between 19 and 80 years, both inclusive. 2. Patient who express their consent to participate in the study in writing. 3. Patient with a value of the IBS-SS questionnaire = 175.
Exclusion criteria
Exclusion criteria: 1. Patient with hypersensitivity or individual allergy to one or more components of the formulation. 2. Patient with a diagnosis of malignancy, heart failure, severe lung disease or infectious disease. 3. Patient who has at least one of the following symptoms or illnesses: - Anemia given by hemoglobin levels below 110 g / L or 11 g / dL. - Chronic digestive hemorrhage. - Progressive loss of involuntary weight given by a loss of at least 10% of body weight in six months or 5% in the last month. - Anorexia nervosa. - Cyclical vomiting that compromises the hydromineral balance or does not allow or prevent proper nutrition or treatment. - Cachexia. 4. Patient with involvement in renal and hepatic function, given by: - Kidney function: Creatinine with values outside the normal limits established in the laboratory of the institution. - Liver function: Transaminases (TGP and TGO) with values higher than twice the value of the normal upper limit established in the laboratory of the institution. 5. Obese patient (BMI=30). 6. Patient with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up. 7. Pregnant or lactating woman. 8. Patient with reproductive and sexually active capacity who does not accept to use at least one contraceptive method. 9. Patient diagnosed with chronic pancreatitis. 10. Patient with decompensated intercurrent diseases that, at the discretion of the physician, could endanger the safety of the patient and / or compliance with the study procedures by the patient, such as: metabolic, electrolyte or other disorders. 11.Patient who requires starting treatment with antidepressants and / or steroids. 12. Patient who received treatment with antibiotics and / or steroids in the month prior to inclusion in the study. 13. Patient who in the two weeks prior to inclusion in the study received treatment with drugs not allowed as concomitant therapies. 14. Patient who consumes probiotic yogurt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Irritable Bowel Syndrome-IBS (Reduction of the severity of IBS measured by the Bowel Syndrome Severity Score-IBSSS (Francis) at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage). | — |
Secondary
| Measure | Time frame |
|---|---|
| Related to efficacy: 1. Intensity of pain (Change of the value of this item in the IBSSS (Francis) questionnaire at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage). 2. Intensity of abdominal distension (Change of the value of this item in the IBSSS (Francis) questionnaire at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage). 3. Changes in bowel habit (Change of the value of this item in the IBSSS (Francis) questionnaire at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage). 4. Quality of Life (IBS-QOL questionnaire). Measurement time: At baseline and, week 12 (in each stage) Note: The baseline value of the stage 2 is recorded in the second week of this stage. This week corresponds with the week 14 if both stage are considered in a same timeline. Related to safety: 5. Adverse events-AE (Reported by the patient and by laboratory tests measured as: Occurrence of an AE (Yes, No); Description of the AE (Name of the adverse event); Duration of the AE (Difference between start and finish of AE); Intensity of the AE (Mild, Moderate, Severe, AE that threatens or incapacitates and AE that causes death); Severity of the AE (Serious/serious, Not serious/not serious); Treatment under study (No changes, Dose modification, Temporary interruption, Definitive interruption of treatment under study); AE result (Recovered, Improved, Persists, Squeals); Causal relationship (1. Definitive 2. Very Likely, 3. Likely, 4. Possible, 5. Unrelated 6. Unknown)). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second | — |
Countries
Cuba
Contacts
Public ContactYinet Barrese Perez
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed