General information Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Phase III clinical trial, prospective randomized, of superiority, to evaluate the efficacy and safety of Colilen IBS vs. placebo in Irritable Bowel Syndrome. Batch comparability study.
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
National Coordinator Center of Clinical Trials (CENCEC)
Source(s) of monetary or material support:
Aboca SpA Società Agricola laboratoriesCuban Ministry of Public Health (MINSAP)
Authorization for beginning Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
Medical Specialty :
1st grade specialist in Gastroenterology
Affiliation:
National Institute of Gastroenterology
Postal address:
25 Street No. 503% H and I
Clinical sites to participate Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Research ethics committees:
National Institute of Gastroenterology, in review
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
Health condition and Intervention Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Health condition(s) code:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intervention(s):
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: 2 capsules by oral route, three times a day, between 30 minutes and 2 hours before meals, for 12 weeks.
Stage 2:
Group I (Experimental) - Colilen IBS (Batch B): 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 (Experimental) - Colilen IBS (Batch C): 2 capsules of 587 mg by oral route, three times a day, between 30 minutes and 2 hours before meals, for 12 weeks.
Intervention code:
Equipment and Supplies
Biological Products
Plant Extracts
Capsules
Administration, Oral
Placebos
Intervention keyword:
Colilen,
Medical device,
Cytoprotective
Outcomes and Timepoint Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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).
Key secondary outcomes:
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 stage).
Selection criterias Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
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:
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.
Study design Section to complete information about the characteristics of the study design.
Allocation:
Randomized controlled trial
Contact for public queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
Specialty:
Bachelor of Pharmaceutical Sciences, Master in Clinical Pharmacy.
Affiliation:
National Coordinator Center of Clinical Trials (CENCEC)
Contact for scientific queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
Specialty:
1st grade specialist in Gastroenterology
Affiliation:
National Institute of Gastroenterology
Postal Address:
25 Street No. 503% H and I
Data Sharing Section to complete the data related to the data sharing plan.
Registration and Update Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
