Health Condition 1: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: Probiotic Bacillus Coagulans: Dose:Take one capsules or as directed, best taken prior to a meal.
Frequency:One Capsule or as directed
Route of Administration: Oral
Total Duration of suc
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 |
|---|---|
| The maximum achievable score was 500 and cases were indicated by scores of Mild: - 75 to 175 Moderate:175 to 300 Severe: Greater than 300 Timepoint: Baseline-Day 1:Genetic markers associated with protein metabolism, inflammation, gut microbiome interactions, and immune response will be assessed. +Day 45-Interim Visit:Genetic markers associated with protein metabolism, inflammation, gut microbiome interactions, and immune response will be re- assessed. Day 90-End of Study:Genetic markers associated with protein metabolism, inflammation, gut microbiome interactions, and immune response will be re- assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Probiotic–Bacillus Clausii Strain in patients with irritable bowel syndrome.Timepoint: Baseline [Day 1]:Genetic markers associated with protein metabolism, inflammation, gut microbiome interactions, and immune response will be assessed. | — |
Countries
India
Contacts
Public ContactDr Suman G
Rajalakshmi Hospital & Research Center
Outcome results
None listed