Health Condition 1: K580- Irritable bowel syndrome with diarrhea
Conditions
Interventions
Intervention1: Probiotic containing B.
coagulans: 106-108 CFU in the form of
powder to be reconstituted in
water to be consumed in
morning and evening (one
each)
Control Intervention1: Placebo: 106-10
Sponsors
Abode Biotec India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female 2.18 - 65 years old 3.Signed informed consent 4.IBS-Diarrhea patient satisfying Rome III criteria.
Exclusion criteria
Exclusion criteria: 1.The patient will be excluded from the study if assessment by the treating investigator showed an evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration 2.Pregnant or lactating women. 3.Females at childbearing age will be excluded unless they are using acceptable birth control measures (i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner). 4.Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the overall symptoms relief between the intervention group and the placebo group as assessed by IBS SSSTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Difference in hematological parameters and lipid profile biomarkers in-between 2 groups over the study period. 2.Differences in stool consistency and frequency per day in-between 2 groups over the study periodTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDivya C
Bioagile Therapeutics Pvt. Ltd
Outcome results
None listed