PrebioticNCT07880327
Psyllium Husk in Pediatric IBS
A study testing Psyllium Husk and Conventional therapy group in people with Prebiotic and IBS (Irritable Bowel Syndrome), run by Eman ElHaddad.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Prebiotic, IBS (Irritable Bowel Syndrome), Psyllium
- What is being tested?
- Psyllium Husk and Conventional therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6-18 years.
- Meet the diagnostic criteria for irritable bowel syndrome (IBS) according to the Pediatric Gastrointestinal Symptoms Rome IV criteria.
Who cannot join
- 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.
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- 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.
About this study
Official title: Psyllium Husk Supplementation in Pediatric Irritable Bowel Syndrome: Effects on Symptoms, Quality of Life and Gut Microbiota
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.
Read the 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.
- Being tested
- Psyllium Husk, Conventional therapy group
- Keywords
- Prebiotics in pediatric irritable bowel syndrome, Psyllium in pediatric IBS, Quality of life in pediatric IBS, Microbiota in pediatric IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium HuskDietary supplement
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 therapy groupOther
Conventional management for pediatric irritable bowel syndrome according to the study protocol, including cognitive behavioral therapy and appropriate pharmacological treatment according to predominant symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | 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. Receives: Other: Conventional therapy group |
| Psyllium Supplementation Plus Conventional Therapy | Experimental | 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. Receives: Dietary Supplement: Psyllium Husk; Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 Weeks, and 12 Weeks.
Secondary outcomes (1)
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrebioticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman ElHaddad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman ElHaddad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880327
- Sponsor's protocol ID
- Psyllium in pediatric IBS 1820
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psyllium Husk Supplementation in Pediatric Irritable Bowel Syndrome: Effects on Symptoms, Quality of Life and Gut Microbiota
- ClinicalTrials.gov ID
- NCT07880327
- Acronym / sponsor ID
- Psyllium in pediatric IBS 1820
- Keywords
- Prebiotics in pediatric irritable bowel syndrome, Psyllium in pediatric IBS, Quality of life in pediatric IBS, Microbiota in pediatric IBS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Eman ElHaddadUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Other: Conventional therapy groupParticipants 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. |
| Psyllium Supplementation Plus Conventional Therapy | Experimental | Dietary Supplement: Psyllium Husk, Other: Conventional therapy groupParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged 6-18 years.
- Meet the diagnostic criteria for irritable bowel syndrome (IBS) according to the Pediatric Gastrointestinal Symptoms Rome IV criteria.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psyllium HuskPsyllium 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). | Dietary supplement | Psyllium Supplementation Plus Conventional Therapy |
| Conventional therapy groupConventional management for pediatric irritable bowel syndrome according to the study protocol, including cognitive behavioral therapy and appropriate pharmacological treatment according to predominant symptoms. | Other | Conventional Therapy, Psyllium Supplementation Plus Conventional Therapy |
Primary outcome
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from Baseline to 12 Weeks
Time frame: 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
Time frame: 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.
1 secondary outcome
Change in Fecal Gut Microbiota Composition from Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium Husk and Conventional therapy group in people with Prebiotic and IBS (Irritable Bowel Syndrome), run by Eman ElHaddad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from Baseline to 12 Weeks (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.