An interventional study of Psyllium Husk and Conventional therapy group in Prebiotic, IBS (Irritable Bowel Syndrome) and Psyllium, sponsored by Eman ElHaddad. Not yet recruiting. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Eman ElHaddad · Not applicable, Interventional, and Treatment
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.
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.
1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →This is the only study on the registry with Eman ElHaddad as lead sponsor.
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Exclusion Criteria:
Participants will receive conventional management for pediatric irritable bowel syndrome according to the study protocol, including cognitive behavioral therapy and appropriate pharmacological treatment according to the predominant symptoms. Pharmacological options include antispasmodics for abdominal pain and appropriate treatment for constipation- or diarrhea-dominant IBS.
Other: Conventional therapy group
Participants will receive the same conventional management as the control group, with the addition of psyllium supplementation. The psyllium dose will be administered according to age as specified in the study protocol.
Dietary Supplement: Psyllium Husk · Other: Conventional therapy group
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).
Conventional management for pediatric irritable bowel syndrome according to the study protocol, including cognitive behavioral therapy and appropriate pharmacological treatment according to predominant symptoms.
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from 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.
Time frame: Baseline to 12 weeks
Change in Irritable Bowel Syndrome Quality of Life Score (IBS-QOL) from Baseline to 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.
Time frame: Baseline, 6 Weeks, and 12 Weeks.
Change in Fecal Gut Microbiota Composition from 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.
Time frame: Baseline to 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Psyllium husk