Psyllium for Pediatric IBS

(Psyllium Trial)

Overseen By Joan Wilson, BSN, MPH

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Dr Bruno Chumpitazi, M.D.

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Bowel surgery, GI disorders, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether psyllium, a type of fiber, can reduce symptoms of irritable bowel syndrome (IBS) in children who consume certain sugars called fructans. Researchers aim to determine if psyllium alters how gut bacteria process these sugars and if it can alleviate belly pain and other IBS symptoms. Participants will follow different diets, track symptoms, and provide samples for testing. Children who have experienced IBS symptoms for a while and notice worsening after eating fructans might be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been on antibiotics or probiotics in the last 3 months, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that psyllium is usually safe and well-tolerated for children with irritable bowel syndrome (IBS). Past studies found that psyllium helped reduce stomach pain and improve bowel movements in kids with IBS. Evidence suggests there are few serious side effects. However, some children might experience mild side effects like bloating or gas, common with fiber supplements. Current research doesn't fully support regular use of psyllium for managing IBS in children, but ongoing studies aim to provide clearer answers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IBS?

Researchers are excited about using psyllium for pediatric IBS because it offers a natural, fiber-based approach that differs from typical treatments like antispasmodics and laxatives. Psyllium works by absorbing water in the gut, which can help regulate bowel movements and ease discomfort, offering a gentle alternative to medications that often come with side effects. Additionally, the inclusion of fructans in the treatment may enhance gut health by promoting beneficial bacteria, providing a dual-action benefit not typically seen in standard care.

What evidence suggests that psyllium might be an effective treatment for pediatric IBS?

Research has shown that psyllium can help treat IBS in children. In earlier studies, psyllium husk reduced stomach pain in kids with IBS, even when mental factors weren't considered. Another study found that psyllium provided better short-term relief of IBS symptoms in children than a placebo. This trial will administer different dosages of psyllium combined with fructans, or a placebo, to evaluate its effectiveness in managing IBS by reducing pain and improving bowel movements. ^{6 7 8 9 10}

Who Is on the Research Team?

Bruno Chumpitazi, MD, MPH

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for children aged 12-17 with pediatric IBS, who meet specific criteria (Rome IV) for the condition. It's designed to see if psyllium fiber helps with their symptoms when they eat foods containing fructans.

Inclusion Criteria

I am a child aged 12-17 with diagnosed IBS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Dietary Assessment

Participants eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms

1 week

2 visits (in-person)

Baseline

Two weeks of baseline with no change in diet

2 weeks

1 visit (in-person)

Treatment

Participants eat a specific diet with fructans with either psyllium or glucose, complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in bloating, abdominal pain, and flatulence severity

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psyllium

Trial Overview

The study tests two different doses of psyllium fiber against a placebo while participants consume fructans. Researchers will monitor changes in gut bacteria activity and whether this affects IBS symptoms like pain and stool consistency.

How Is the Trial Designed?

Group I: Psyllium (0.7 g/year of age per day) given with fructans Active Control 2 Interventions

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)

Group II: Psyllium (0.5 g/year of age per day) given with fructans Active Control 2 Interventions

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)

Group III: Placebo (0.7 g/year of age glucose) given with fructans Placebo Group 2 Interventions

Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams).

Who Is Running the Clinical Trial?

Dr Bruno Chumpitazi, M.D.

Lead Sponsor

Trials

1

Recruited

110+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 509 pediatric IBD patients, 25.9% experienced adverse events (AEs) that required discontinuation of their medication, highlighting the prevalence of drug-related complications in this population.

Immunomodulators and TNF-alpha antagonists were the most common drugs associated with AEs leading to treatment cessation, and using three or more medications simultaneously significantly increased the risk of these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Related Adverse Events Necessitating Treatment Discontinuation in Pediatric Inflammatory Bowel Disease Patients. Salzmann, M., von Graffenried, T., Righini-Grunder, F., et al.[2023]

Out of over 3.4 million adverse reaction reports analyzed, 7.7% were for children, with skin reactions being the most common, highlighting the need for careful monitoring of drug safety in pediatric populations.

Recent years have seen an increase in reports of medication errors and adverse reactions related to ADHD medications in children, particularly in younger age groups, indicating a need for improved safety measures and education regarding drug administration in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. Star, K., Norén, GN., Nordin, K., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36136861/

EFFICACY OF ORAL PSYLLIUM IN PEDIATRIC ...

Psyllium husk is effective for the therapy of pediatric IBS when compared with placebo in short term.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06639984

Study Details | NCT06639984 | Psyllium in Pediatric IBS

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 ...

3.

cghjournal.org

cghjournal.org/article/s1542-3565(16)30021-0/fulltext

Psyllium Fiber Reduces Abdominal Pain in Children With ...

Psyllium fiber reduced the number of abdominal pain episodes in children with IBS, independent of psychological factors. Psyllium did not alter breath hydrogen ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1542356516300210

Psyllium Fiber Reduces Abdominal Pain in Children With ...

Psyllium fiber reduced the number of abdominal pain episodes in children with IBS, independent of psychological factors. Psyllium did not alter breath hydrogen ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1097/MPG.0000000000003622

Efficacy of Oral Psyllium in Pediatric Irritable Bowel ...

Psyllium husk is effective for the therapy of pediatric IBS when compared with placebo in short term. REFERENCES.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06639984

Study Details | NCT06639984 | Psyllium in Pediatric IBS

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 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5064811/

Psyllium Fiber Reduces Abdominal Pain in Children With ...

We sought to determine the efficacy of psyllium fiber treatment on abdominal pain and stool patterns in children with irritable bowel syndrome (IBS).

8.

cghjournal.org

cghjournal.org/article/S1542-3565(16)30274-9/fulltext

Should We Treat Our Pediatric Irritable Bowel Syndrome ...

In our opinion, these data do not provide enough evidence to support the routine use of psyllium fiber in the management of children with IBS.

9.

link.springer.com

link.springer.com/article/10.1007/s40746-025-00339-3

Pediatric Irritable Bowel Syndrome: Current Understanding ...

Although the role of PEG 3350 in managing IBS in children is not well established, some data demonstrates effectiveness in relieving ...

10.

researchgate.net

researchgate.net/publication/363787770_EFFICACY_OF_ORAL_PSYLLIUM_IN_PEDIATRIC_IRRITABLE_BOWEL_SYNDROME_A_DOUBLE_BLIND_RANDOMISED_CONTROL_TRIAL

(PDF) Efficacy of Oral Psyllium in Pediatric Irritable Bowel ...

Psyllium husk is effective for the therapy of Pediatric IBS when compared with placebo in short term.