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Comparison of efficacy of fiber (Ispaghula husk) and simple sugar (maltrodextrin) in functional abdominal pain in children

Randomized placebo-controlled trial of Psyllium fiber in functional abdominal pain disorders in children. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056772
Enrollment
100
Registered
2023-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: K598- Other specified functional intestinal disorders

Interventions

Intervention1: Psyllium husk: Children with functional abdominal pain disorders randomized to intervention arm will receive psyllium husk (5g in 5-11 years and 10g in 12-18 years) for 12 weeks Control

Sponsors

Dr Ujjal Poddar
Lead Sponsor
Sanjay Gandhi Post Graduate Institue of Meical Sciences
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children of 5 to 18 years of age, diagnosed as FAPD as per ROME IV criteria will be recruited from pediatric gastroenterology outpatient services of Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.

Exclusion criteria

Exclusion criteria: 1.Underlying organic disease. 2.Functional dyspepsia as its pathophysiology is different. 3.Already on fiber therapy in any form 4.Child is on other pain modulating medication such as amitriptyline, antispasmodics or anti-depressants. (Only PCM will be allowed for pain management) 5.Child on laxatives such as PEG, a wash off period of 4 weeks (off laxative) will be required to be included in the study.

Design outcomes

Primary

MeasureTime frame
Primary objective: Pain relief with psyllium fiberTimepoint: During therapy & at the end of 12 weeks trial

Secondary

MeasureTime frame
Quality of life (QOL) & occasions requiring analgesics (oral/parenteral) during pain episodesTimepoint: During therapy & at the end of 12 weeks trial

Countries

India

Contacts

Public ContactDr Manjit Kaur

Sanjay Gandhi Post Graduate Institute of Medical Sciences

msaini734@gmail.com8699340161

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 6, 2026