Health Condition 1: null- Irritable Bowel Syndrome
Conditions
Interventions
Intervention1: UBLAC-Containg Bacillus coagulans-2 Billion CFU: One chewable tablet of UBLAC is to be taken orally per day For a period of 8 weeks.
Control Intervention1: Placebo: One Chewable tablet
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children of either sex having age group 4-12 years.(Both inclusive). 2. Must include all of the following criteria (Rome III Criteria) A.Abdominal discomfort or pain associated with two or more of the following at least 25% of the time: a)Improvement with defecation b)Onset associated with a change in frequency of stool c)Onset associated with a change in the form (appearance) of stool B. No evidence ofan inflammatory, anatomic, metabolic or neoplastic process that explains the subjectâ??s symptoms. 3. Presence of any of the following symptoms: abnormal stool frequency defined as greater than 3 bowel movements per day or less than bowel movements per week; abnormal stool form (lumpy/hard or loose/watery); abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus with stool; and bloating or feeling of abdominal distension. (Bristol Stool Scale) 4. Childrenâ??s (if age of the child is>= 4 and <=12 years, consent will be signed by their parents) and their parents who are able to read or understand child assent form and parents consent form and willing to give consent respectively.
Exclusion criteria
Exclusion criteria: 1. Patients presenting any disease that may affect bowel motility other than the clinical diagnosis of IBS. 2. History of lactose intolerance and other malabsorption syndromes (e.g. fructose malabsorption) 3. Previous abdominal surgery and patients suffering from severe systemic disease. 4. Patients who had been using any commercial preparation of probiotics in last 3 months. 5. History of digestive disease (ulcerative colitis, esophagitis, peptic ulcer, celiac disease) or symptoms suggestive of rectal bleeding and weight loss. 6. Acute gastroenteritis in the last 4 weeks prior to inclusion. 7. Patient having calprotectin value greater than 500 μg/g stool
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Outcome: 1. Physical Examination and Vitals 2. Assessment of Adverse Event Reports, if any 3. Assessment of Laboratory parameters. Efficacy Outcome: Reduction of discomfort/pain intensity â?? assessed by physician.Timepoint: Safety Outcome: 1. Physical Examination and Vitals [Screening, Baseline, Week 6, Week 10] Assessment of Adverse Event Reports, if any [Baseline, Week 6, Week 10 and Week 12] 3. Assessment of Laboratory parameters. [Screening and Week 10] Efficacy Outcome: Reduction of discomfort/pain intensity â?? assessed by physician. [Screening, Baseline, Week 6, Week 10 and Week 12] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall change in severity of symptoms. 2. Relief of stool disturbance â?? number and consistency 3. SGARCâ??Subjectâ??s Global Assessment of Relief for Children with IBS. 4. Rescue/Concomitant medication.Timepoint: 1. Overall change in severity of symptoms [Baseline, Week 6, Week 10] 2. Relief of stool disturbance â?? number and consistency [Baseline Week 6, Week 8] 3. SGARCâ??Subjectâ??s Global Assessment of Relief for Children with IBS [Baseline and Week 4, Week 8] 4. Rescue/Concomitant medication [Baseline and Week 6, Week 10 ,week 12] | — |
Countries
India
Contacts
Public ContactDr Jayanthi Neelamraju
Unique Biotech Ltd.
Outcome results
None listed