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 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

暂无简介。

•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

•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

发起方

Hexagon Nutrition Limited