Health Condition 1: K590- Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged between 4-12 years 2. Satisfying ROME IV criteria
Exclusion criteria
Exclusion criteria: 1. History of mechanical intestinal obstruction, post-surgical intestinal adhesions, pseudo-obstruction, irritable bowel syndrome. 2. Developmental delay, neurological manifestations. 3. Failure to thrive, bilious vomiting, or developmental malformation. 4. Intake of codeine, dextromethorphan, stool softeners in last 3 months 5. Coexisting severe acute systemic illness (pneumonia, sepsis, UTI, other co-morbidities). 6. Diagnosed case of immune deficiency 7. Subject’s parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in constipation severity Assessed through PAC-SYQ questionnaire Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in stool frequency 2. Stool pattern 3. Abdominal pain 4. Time required for improvement in constipation related symptoms. 5. Adverse events Timepoint: 4 weeks | — |
Countries
India
Contacts
UCMS and GTB Hospital