Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: PentaSure Fiber: 1 scoop approx. 10 gm per serving for 10 days preferably at night
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Hexagon Nutrition Limited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in stool frequency during supplementation ie Day 0 to Day 10 On Day 2 Day 7 and Day 10 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 Timepoint: 1 Day 0 to Day 10 On Day 2 Day 7 and Day 10 2 Day 0 and Day 10 On Day 2 Day 7 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in stool frequency post supplementation from Day 11 to Day 17 2 Treatment recovery Recovery is defined as the child having betterment or no symptoms of constipation according to the Rome IV criteria i e Day 0 to Day 10 3 Usage of any laxative or rescue medication apart from the investigational product 4 Number of clinical or Hospital visits during the study period both planned and unplanned 5 The prevalence of constipation recurrence during the study period i e from Day 11 to Day 17 6 Failure of maintaining normal bowel movements post treatment with PentaSure Fiber and the need to resume PentaSure Fiber treatment from Day 11 to Day 17 7 Change in stool consistency without PentaSure Fiber consumption using the Bristol scale from Day 11 to Day 17 8 Change in abdominal pain from baseline to end of treatment i e Day 0 to Day 10 9 Presence of abdominal pain during post supplementation period i e Day 11 to Day 17Timepoint: 1 Day 11 to Day 17 On Day 17 2 Day 0 to Day 10 On Day 2 Day 7 and Day 10 3 Throughout the study 4 Throughout the study 5 Day 11 to Day 17 On Day 17 6 Day 11 to Day 17 On Day 17 7 Day 11 to Day 17 On Day 17 8 Day 0 to Day 10 On Day 2 Day 7 and Day 10 9 Day 11 to Day 17 On Day 17 | — |
Countries
India
Contacts
Public ContactDr Sujay Gowda
Hexagon Nutrition Private Limited
Outcome results
None listed