Comparison of efficacy of fiber (Ispaghula husk) and simple sugar (maltrodextrin) in functional abdominal pain in childre
Phase 4
- Conditions
- Health Condition 1: K598- Other specified functional intestinal disorders
- Registration Number
- CTRI/2023/08/056772
- Lead Sponsor
- Dr Ujjal Poddar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective: Pain relief with psyllium fiberTimepoint: During therapy & at the end of 12 weeks trial
- Secondary Outcome Measures
Name Time Method Quality of life (QOL) & occasions requiring analgesics (oral/parenteral) during pain episodesTimepoint: During therapy & at the end of 12 weeks trial