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Study conducted to know the effect of Psyllium husk over an inert drug on pediatric irritable bowel syndrome

Efficacy of Oral Psyllium versus Placebo in Pediatric Irritable Bowel Syndrome: A Double Blind Randomized Control Trial (Superiority Trail)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021706
Enrollment
90
Registered
2019-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Pediatric Irritable Bowel syndrome

Interventions

Intervention1: Psyllium husk: Dietary fiber 6 g/day for 4 -12 years age and 12 g for 13 to 18 years Dosing : Twice daily in 2 divided doses Route : Oral Duration : 4 weeks Control Intervention1:

Sponsors

Jagadeesh Menon V R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Criteria of Pediatric IBS ROME 4

Exclusion criteria

Exclusion criteria: Children with IBS already on drug therapy or suffering from chronic diseases including, cardiac, renal and hepatic, failure to thrive, bronchial asthma, prior GI surgeries, malignancies, celiac disease, inflammatory bowel disease, cystic fibrosis, anatomical malformations of the gut, immune deficiencies, hypothyroidism, neurological and muscle diseases, and anatomical causes of bowel dysfunction will ruled out by clinical, laboratorial and radiological investigations. Child not on antibiotic therapy for atleast 4 weeks prior to enrollment

Design outcomes

Primary

MeasureTime frame
Symptom response to Psyllium VERSUS placebo as per IBS Severity scoring systmemTimepoint: symptom response after 4 weeks of starting medications

Secondary

MeasureTime frame
IL 6 and IL 10 levels at baseline and 4 weeks post intervention in the two drug limbsTimepoint: 4 WEEKS;Small intestinal bacterial overgrowth and its response to therapyTimepoint: 4 weeks

Countries

India

Contacts

Public ContactJagadeesh Menon

PGIMER, Chandigarh

brthapa1@yahoo.co.in9888552023

Outcome results

None listed

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