Health Condition 1: K590- Constipation Health Condition 2: null- Functional constipation
Conditions
Interventions
Intervention1: Laxopeg: Polyethylene Glycol 3350 - powder 1 sachet to be stirred in 100-200 ml or 8 ounce of water (0.7gâ??1.5 g/ kg body weight) orally once daily for 4 weeks
Control Intervention1:
Sponsors
Fourrts India Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged 2 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: 1. 2 or fewer defecations /week. 2. History of excessive stool retention 3. History of painful or hard bowel movements. 4. Presence of a large faecal mass in the rectum 5. History of a large diameter stool 2. Parent of the subjects must give written informed consent for study participation. 3. Parent of the subjects must be willing to maintain subject diary and follow all instructions as per the study protocol. 4. If patient has already consumed any laxative for the current episode, then a wash-out period of about 2 weeks to be given before administering study medication.
Exclusion criteria
Exclusion criteria: 1. Subjects with intestinal pseudo obstruction. 2. Subjects who are debilitated or seriously ill or immunocompromised. 3. Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc. 4. Patients with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohnâ??s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose). 5. Subjects with hypersensitivity to any ingredient in the formulation. 6. Subjects with history of surgery involving the colon or anus. 7. Participation in any clinical trial in the last 3 months prior to screening. 8. 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 |
|---|---|
| PEG 3350 vs Lactulose in children with functional constipation , to assess the weekly changes in frequency of stool passed and no. of painful bowel movement per weekTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring of AEs and SAE s and assesment of acceptibility through Likart scaleTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt. Ltd.
Outcome results
None listed