Irritable Bowel SyndromePhase 2PsylliumNCT06639984
Psyllium in Pediatric IBS
A Phase 2 study testing Psyllium (0.7 g/year of age per day), Psyllium (0.5 g/year of age per day) and fructans in people with Irritable Bowel Syndrome, run by Dr Bruno Chumpitazi, M.D. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Psyllium (0.7 g/year of age per day), Psyllium (0.5 g/year of age per day) and fructans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 30 Sep 2027
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
Who cannot join
- Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
- weight and/or height are \> or \< 2 SD for age
- have chronic conditions with GI symptoms (e.g., cystic fibrosis)
- have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
- girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Annette Babu, 9196601227, annette.babu@duke.edu
Bruno Chumpitazi
About this study
Official title: Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are:
Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics).
Read more
Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms.
Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Psyllium (0.7 g/year of age per day), Psyllium (0.5 g/year of age per day), Placebo, fructans
- Keywords
- Abdominal Pain
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium (0.7 g/year of age per day)Drug
Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
Psyllium (0.5 g/year of age per day)Drug
Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD)
PlaceboDrug
Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK)
fructansOther
Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1
| Study group | Role | What they receive |
|---|---|---|
| Psyllium (0.7 g/year of age per day) given with fructans | Active comparator | Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams) Receives: Drug: Psyllium (0.7 g/year of age per day); Other: fructans |
| Psyllium (0.5 g/year of age per day) given with fructans | Active comparator | Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams) Receives: Drug: Psyllium (0.5 g/year of age per day); Other: fructans |
| Placebo (0.7 g/year of age glucose) given with fructans | Placebo comparator | Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams). Receives: Drug: Placebo; Other: fructans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Measured: Baseline, 2 weeks
Change in fecal lactate
Measured: Baseline, 2 weeks
Change in fecal short-chain fatty acids
Measured: Baseline, 2 weeks
Change in hydrogen gas production
Measured: Baseline, 2 weeks
Change in fecal fructans
Measured: Baseline, 2 weeks
Secondary outcomes (4)
Change in abdominal pain frequency
Measured: Baseline, 2 weeks
Change in abdominal pain severity
Participants will rate abdominal pain on a scale of 0-10, with higher scores indicating more severe pain.
Measured: Baseline, 2 weeks
Change in bloating severity
Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating.
Measured: Baseline, 2 weeks
Change in flatulence severity
Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Feb 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Bruno Chumpitazi, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Bruno Chumpitazi, M.D., Duke University
- Investigators
- Bruno Chumpitazi, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639984
- Sponsor's protocol ID
- Pro00114630
- Acronym
- Psyllium
- Status last verified
- May 2026
- First submitted
- 25 Sep 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Psyllium Given With Meals for Fructan Sensitivity in Children With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06639984
- Acronym / sponsor ID
- Psyllium / Pro00114630
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Abdominal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dr Bruno Chumpitazi, M.D.University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are:
Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics).
Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms.
Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psyllium (0.7 g/year of age per day) given with fructans | Active comparator | Drug: Psyllium (0.7 g/year of age per day), Other: fructansParticipants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams) |
| Psyllium (0.5 g/year of age per day) given with fructans | Active comparator | Drug: Psyllium (0.5 g/year of age per day), Other: fructansParticipants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams) |
| Placebo (0.7 g/year of age glucose) given with fructans | Placebo comparator | Drug: Placebo, Other: fructansParticipants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
Key exclusion criteria (5 listed)
- Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
- weight and/or height are \> or \< 2 SD for age
- have chronic conditions with GI symptoms (e.g., cystic fibrosis)
- have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
- girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)
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 (0.7 g/year of age per day)Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD) | Drug | Psyllium (0.7 g/year of age per day) given with fructans |
| Psyllium (0.5 g/year of age per day)Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD) | Drug | Psyllium (0.5 g/year of age per day) given with fructans |
| PlaceboPlacebo (0.7 g/year of age glucose) (Staleydex 333; Tate \& Lyle, Staley, London, UK) | Drug | Placebo (0.7 g/year of age glucose) given with fructans |
| fructansDaily dose 0.5 g/kg up to 19 grams, Orafti Synergy1 | Other | Placebo (0.7 g/year of age glucose) given with fructans, Psyllium (0.5 g/year of age per day) given with fructans, Psyllium (0.7 g/year of age per day) given with fructans |
Primary outcome
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing
Time frame: Baseline, 2 weeks
Change in fecal lactate
Time frame: Baseline, 2 weeks
Change in fecal short-chain fatty acids
Time frame: Baseline, 2 weeks
Change in hydrogen gas production
Time frame: Baseline, 2 weeks
Change in fecal fructans
Time frame: Baseline, 2 weeks
4 secondary outcomes
Change in abdominal pain frequency
Time frame: Baseline, 2 weeks
Change in abdominal pain severity
Time frame: Baseline, 2 weeks
Change in bloating severity
Time frame: Baseline, 2 weeks
Change in flatulence severity
Time frame: Baseline, 2 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 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
Recruiting
Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
IBS, Ulcerative Colitis, Active
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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.
Bruno Chumpitazi, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psyllium (0.7 g/year of age per day), Psyllium (0.5 g/year of age per day) and fructans in people with Irritable Bowel Syndrome, run by Dr Bruno Chumpitazi, M.D. at 1 site in United States.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Bruno Chumpitazi, MD, MPH (919-660-1227, bruno.chumpitazi@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing (time frame: Baseline, 2 weeks). The study lists 5 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 26 May 2026.