None listed
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: 106-1
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. o Recurrent abdominal pain or discomfort, 3 days per month in the last 3 months (12 weeks), associated with >= 2 of the criteria below. The criteria are fulfilled with symptoms onset 6 months prior to diagnosis:
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.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) 5.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) 6. 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. 7.Patients exceeding the treatment limits of permitted medication [(more than 2 days/week during the study period): alginate, antacids and analgesics (limited to acetaminophen 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric anti secretory agents (only for GERD patients who are on a stable dose > 3 months; patients should be able to differentiate between IBS and GERD symptoms), acetylsalicylic acid 8.Being in another clinical trial 4 weeks before entering the study 9.Constipated IBS patients 10.IBS-Diarrhea patients with un-treated lactose intolerance 11.Regular use of probiotics or using other probiotics during the course of the study 12.Patients allergic to milk or soy products 13.Patients using catheters 14.Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms and a family history of colorectal cancer, inflammatory bowel disease and celiac spruce 15.Patients over 50 diagnosed with Irritable Bowel Syndrome who have not had a colonoscopy in the last 5 years 16.Patients who have allergies for the active ingredients or any of the excipients 17.Patients presented with any immune-compromised condition (such as AIDS, lymphoma, long term corticosteroid treatment) Patients presented with nausea, vomiting and fever.
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: Time Frame 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in stool consistency and frequency/ day between the intervention group and the placebo group over the study period. Differences in hematological parameters and lipid profile biomarkers between the intervention group and the placebo group over the study period. Timepoint: Time Frame 8 weeks | — |
Countries
India
Contacts
Public ContactDivya C
Bio Agile Therapeutics Pvt. Ltd
Outcome results
None listed