To evaluate the effect of PentaSure fibersupplementation in the management of Functional Constipation among Childre

Phase 4

Conditions: Health Condition 1: K928- Other specified diseases of the digestive system

Registration Number: CTRI/2023/10/058430

Lead Sponsor: Hexagon Nutrition Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Children aged between 6 to 12 years of either sex presenting to the outpatient department of the hospital with a clinical diagnosis of functional constipation and fecal incontinence according to the Rome IV criteria at least 2 of the following

a 2 or fewer defecations per week

b History of excessive stool retention

c History of painful or hard bowel movements

d Presence of a large fecal mass in the rectum

e History of a large diameter stool

2 Parent of the child must give written informed consent for study participation

3 Parent of the child must be willing to maintain subject diary and follow all instructions as per the study protocol

4 Already on any laxative for the current episode then a washout period of about 14 days to be given before administering study investigational product

Exclusion Criteria

1 Child with the symptoms or suspicion of any organic lesion of the digestive tract or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis Crohns disease history of carcinomas of the bowel

2 Subjects with intestinal pseudo-obstruction

3 Immunocompromised

4 Hypersensitivity to any ingredient in the formulation

5 History of surgery involving the colon or anus

6 Participation in any clinical trial in the last 3 months

7 The presence of any other medical or surgical condition which as per the judgment of the principal investigator is not conducive for trial participation

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Change in stool frequency during supplementation ie Day 0 to Day 10 On Day 2 Day 7 and Day 10 <br/ ><br>2 Change in stool consistency with PentaSure Fiber consumption using the Bristol scale i e Day 0 and Day 10 On Day 2 Day 7 and Day 10 <br/ ><br>Timepoint: 1 Day 0 to Day 10 On Day 2 Day 7 and Day 10 <br/ ><br>2 Day 0 and Day 10 On Day 2 Day 7 and Day 10 <br/ ><br>

Secondary Outcome Measures