Health Condition 1: K588- Other irritable bowel syndrome
Conditions
Interventions
Intervention1: Probiotic Bacillus subtilis: Bottle contains 60 capsules.Take one Capsules or as directed, best taken prior to a meal.Each capsule contains 2 billion cfu of active.
Control Intervention
Sponsors
Vidya Herbs Pvt LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least 1 day or week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)]. 2.Patients willing to provide written informed consent and comply to protocol requirements
Exclusion criteria
Exclusion criteria: 1.Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding 2.Known inflammatory bowel disease or celiac disease patients, 3.Immuno-compromised patients 4.Pregnancy or wishing to become pregnant during the study 5.End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases greater than 3.5x above normal) 6.The use of other probiotic products or antibiotics over the previous 6 months 7.Participation in other clinical trials 8.The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who experienced at least one Adverse Event during the study duration 2. Number of participants who discontinued study drug due to an Adverse Event during the study.Timepoint: Baseline-Day 1,Day-45,Day-90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants who experienced at least one Adverse Event during the study duration 2.Number of participants who discontinued study drug due to an Adverse Event during the study.Timepoint: Baseline-Day 1,Day-45,Day-90 | — |
Countries
India
Contacts
Public ContactDr Suman G
Rajalakshmi Hospital
Outcome results
None listed