A double blinded randomized controlled study to investigate the efficacy of UBLAC supplementation versus placebo on Irritable Bowel Syndrome in children between 4-12 years

nique Biotech Limited0 sites154 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

October 3, 2016

Last Updated

4 years ago

Study Type

Interventional

Sponsor

nique Biotech Limited

•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.

•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 Î¼g/g stool