Study conducted to know the effect of Psyllium husk over an inert drug on pediatric irritable bowel syndrome
Phase 4
Completed
- Conditions
- Health Condition 1: null- Pediatric Irritable Bowel syndrome
- Registration Number
- CTRI/2019/10/021706
- Lead Sponsor
- Jagadeesh Menon V R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 81
Inclusion Criteria
Criteria of Pediatric IBS ROME 4
Exclusion Criteria
Children with IBS already on drug therapy or suffering from chronic diseases including, cardiac, renal and hepatic, failure to thrive, bronchial asthma, prior GI surgeries, malignancies, celiac disease, inflammatory bowel disease, cystic fibrosis, anatomical malformations of the gut, immune deficiencies, hypothyroidism, neurological and muscle diseases, and anatomical causes of bowel dysfunction will ruled out by clinical, laboratorial and radiological investigations. Child not on antibiotic therapy for atleast 4 weeks prior to enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom response to Psyllium VERSUS placebo as per IBS Severity scoring systmemTimepoint: symptom response after 4 weeks of starting medications
- Secondary Outcome Measures
Name Time Method IL 6 and IL 10 levels at baseline and 4 weeks post intervention in the two drug limbsTimepoint: 4 WEEKS;Small intestinal bacterial overgrowth and its response to therapyTimepoint: 4 weeks