Prebiotic, IBS (Irritable Bowel Syndrome), Psyllium, Quality of Life (QOL)
Conditions
Keywords
Prebiotics in pediatric irritable bowel syndrome, Psyllium in pediatric IBS, Quality of life in pediatric IBS, Microbiota in pediatric IBS
Brief summary
Children aged 6 to 17 years with IBS will be randomly assigned to either receive psyllium husk supplementation in addition to usual care or receive usual care alone. The study will compare gastrointestinal symptoms, quality of life, and gut microbiota between the two groups.
Detailed description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder in children, characterized by recurrent abdominal pain associated with changes in bowel habits. Symptoms may negatively affect daily activities and quality of life. Dietary and fiber-based interventions are commonly considered as part of the management of IBS. Psyllium husk is a soluble fiber that may have beneficial effects on gastrointestinal symptoms and may influence the intestinal microbiota. This study will investigate the effects of psyllium husk supplementation in children with IBS receiving usual care. The study will evaluate the effect of psyllium husk supplementation on gastrointestinal symptoms, health-related quality of life, and the composition of intestinal microbiota. Participants will be followed during the study period, and outcomes will be compared between children receiving psyllium husk supplementation in addition to usual care and those receiving usual care alone. The study aims to provide clinical information regarding the potential role of psyllium husk supplementation as an adjunct to usual care in children with IBS and to explore its possible effects on the intestinal microbiota.
Interventions
DIETARY_SUPPLEMENTPsyllium Husk
Psyllium husk supplementation administered in addition to conventional therapy. Children aged 6-12 years will receive 6 g/day (3 g twice daily), while adolescents will receive 12 g/day (6 g twice daily).
OTHERConventional therapy group
Conventional management for pediatric irritable bowel syndrome according to the study protocol, including cognitive behavioral therapy and appropriate pharmacological treatment according to predominant symptoms.
Sponsors
Eman ElHaddad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 6-18 years. * Meet the diagnostic criteria for irritable bowel syndrome (IBS) according to the Pediatric Gastrointestinal Symptoms Rome IV criteria.
Exclusion criteria
* Patients with red flags suggestive of gastrointestinal disease, including: * Unintentional weight loss or failure to thrive. * Gastrointestinal bleeding, such as melena, hematochezia, or positive stool occult blood. * Nocturnal or progressively worsening abdominal pain that awakens the child from sleep. * Persistent vomiting, dysphagia, or odynophagia. * Abnormal physical examination findings, such as an abdominal mass or organomegaly. * Systemic symptoms, including fever, rash, or arthritis. * Family history of gastrointestinal cancer or inflammatory bowel disease. * Patients with other comorbidities, including systemic diseases. * Participants or parents who are not cooperative regarding medications and referrals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from Baseline to 12 Weeks | Baseline to 12 weeks | Change in irritable bowel syndrome symptom severity measured using the Irritable Bowel Syndrome Symptom Severity Scoring System (IBS-SSS). Assessments will be performed at baseline, 6 weeks, and 12 weeks. |
| Change in Irritable Bowel Syndrome Quality of Life Score (IBS-QOL) from Baseline to 12 Weeks | Baseline, 6 Weeks, and 12 Weeks. | Change in irritable bowel syndrome-specific quality of life measured using the Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QOL). The questionnaire will be scored according to the instrument's scoring instructions. Assessments will be performed at baseline, 6 weeks, and 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Gut Microbiota Composition from Baseline to 12 Weeks | Baseline to 12 weeks | Change in fecal concentrations of Bifidobacteria, Lactobacilli, Clostridium, and Enterococci measured by quantitative real-time polymerase chain reaction (qRT-PCR) from baseline to 12 weeks. |
Outcome results
None listed