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To see if constipation symptoms improve in Dietary fiber supplement as compared to Dietary advice.

DIETARY FIBER SUPPLEMENT VERSUS PERSONALIZED DIETARY ADVICE IN CHILDREN WITH FUNCTIONAL CONSTIPATION- A RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046419
Enrollment
174
Registered
2022-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: DIETARY FIBER SUPPLEMENT: Subjects will be asked to use psyllium husk, 0.5 gm/kg/day, in water for 4 weeks Control Intervention1: Personalized Dietary Advice.: The patients will be give

Sponsors

Nil
Lead Sponsor

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

MeasureTime frame
Change in constipation severity Assessed through PAC-SYQ questionnaire Timepoint: 4 weeks

Secondary

MeasureTime 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

Public ContactRinku Sharma

UCMS and GTB Hospital

manish_2710@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026