A comparative study of UBLAC vs placebo to evaluate its safety and efficacy in children between 4 - 12 (Both inclusive)

Phase 2

Completed

• Conditions: Health Condition 1: null- Irritable Bowel Syndrome

• Registration Number: CTRI/2017/02/007810
• Lead Sponsor: nique Biotech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-10-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 154

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified