Psyllium for Pediatric IBS

(Psyllium Trial)

Overseen By Joan Wilson, BSN, MPH

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Dr Bruno Chumpitazi, M.D.

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Bowel surgery, GI disorders, Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Trial Summary

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.

What data supports the effectiveness of the treatment psyllium for pediatric IBS?

Psyllium has been shown to improve symptoms in adults with IBS and is commonly recommended by healthcare professionals. Additionally, psyllium has been effective in treating other conditions in children, such as chronic nonspecific diarrhea, where 87% of children responded positively to the treatment. ^{1 2 3 4 5}

Is psyllium safe for children with IBS?

The provided research articles do not contain specific safety information about psyllium for children with IBS. However, they discuss general safety concerns and adverse events related to medications and supplements in children. ^{6 7 8 9 10}

How does the treatment psyllium differ from other treatments for pediatric IBS?

Psyllium is a unique treatment for pediatric IBS because it is a natural, water-soluble fiber that can help regulate bowel movements by adding bulk to the stool, unlike other treatments that may focus on altering gut bacteria or using medications. It is commonly used in adults and is now being studied for its effectiveness in children, offering a potential dietary approach to managing IBS symptoms. ^{1 3 4 5 11}

What is the purpose of this trial?

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.

Research Team

Bruno Chumpitazi, MD, MPH

Principal Investigator

Duke University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Psyllium in Pediatric Irritable Bowel Syndrome: A Double-Blind Randomized Control Trial. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

[The psyllium fibre for the treatment of functional constipation in children]. [2017]

3. Canada pubmed.ncbi.nlm.nih.gov

The role of psyllium fibre supplementation in treating irritable bowel syndrome. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A psyllium-enriched cereal for the treatment of hypercholesterolemia in children: a controlled, double-blind, crossover study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Use of psyllium in the management of chronic nonspecific diarrhea of childhood. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Taking Stock of Dietary Supplements' Harmful Effects on Children, Adolescents, and Young Adults. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Drug-Related Adverse Events Necessitating Treatment Discontinuation in Pediatric Inflammatory Bowel Disease Patients. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Characteristics of adverse medication events in a children's hospital. [2014]

10. Norway pubmed.ncbi.nlm.nih.gov

Safety in paediatric clinical trials--a 7-year review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. [2022]