Health Condition 1: K58- Irritable bowel syndrome
Conditions
Interventions
Intervention1: Probiotika Off Capsule: One capsule of Probiotika off Per day, Oral use, upto 30 days
Contents: Tyndallized LA
Control Intervention1: Placebo Capsule: One capsule of Placebo per day, Or
Sponsors
Nutrin GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex 2. Age 18 - 65 years (both inclusive) 3. Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS: IBS definition will be based on Rome criteria. 4. Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories). 5. Are free of any disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events. 6. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 7. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study. 8. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
Exclusion criteria
Exclusion criteria: 1. Are pregnant, breast-feeding, or planning to become pregnant during the study. 2. Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations) 3. Patients requiring treatments with non permitted medication (i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti-flatulence agents, metoclopramide, gastric-anti secretory agents (proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease (GERD)), narcotics, anti-diarrheal drugs, and systemic steroids) 4. Patients allergic to milk or soy products 5. Patient has a potential central nervous system cause of constipation (e.g., Parkinsonâ??s disease, spinal cord injury, and multiple sclerosis). 6. Patient has ever had a fecal impaction that required hospitalization or emergency room treatment, or has a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unless successful treatment has been documented by a normal balloon expulsion test). 7. Patient has untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the Screening. 8. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments. 9. Have participated in any interventional clinical trial in the previous 30 days. 10. Have a known sensitivity to any of the constituents of the test product 11. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids. 12. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the abdominal pain relief and changes in stool frequency before and after the treatment, between the two arms.Timepoint: Baseline to Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal pain component of the primary end point will be accessed by using an 10 point numeric rating scale that asks patient daily to rate their abdominal pain over the past 24 hours.Timepoint: Baseline and Day 30;quality-of-life parameter as measured by EQ5D before and after treatments, between 2 armsTimepoint: Baseline and Day 30;quality-of-life parameter as measured by IBSSSS before and after treatments, between 2 armsTimepoint: Baseline and Day 30;quality-of-life parameter as measured by SF12v2 before and after treatments, between 2 armsTimepoint: Baseline and Day 30;The defecation component of the primary end point will be evaluated by â??Bristol stool form scaleâ??.Timepoint: Baseline and Day 30 | — |
Countries
India
Contacts
Public ContactPuneet Mittal
Mittal Global Clinical Trial Services
Outcome results
None listed