To see if constipation symptoms improve in Dietary fiber supplement as compared to Dietary advice.
Not Applicable
Completed
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2022/10/046419
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 174
Inclusion Criteria
1. Children aged between 4-12 years
2. Satisfying ROME IV 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in constipation severity <br/ ><br> Assessed through PAC-SYQ questionnaire <br/ ><br>Timepoint: 4 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Change in stool frequency <br/ ><br> <br/ ><br>2.Stool pattern <br/ ><br> <br/ ><br>3.Abdominal pain <br/ ><br> <br/ ><br>4.Time required for improvement in constipation related symptoms. <br/ ><br>5.Adverse events <br/ ><br>Timepoint: 4 weeks