CTRI/2023/10/058430
Not yet recruiting
Phase 4
An open-label study to evaluate the safety, efficacy, and acceptability of PentaSure soluble fiber supplementation for the management of Functional Constipation in Children. A post-marketing surveillance clinical study - Nil
Hexagon Nutrition Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Sponsor
- Hexagon Nutrition Limited
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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