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Fiber Supplement

Psyllium for Functional Abdominal Pain Syndrome

N/A

Waitlist Available

Led By Gerald Giesbrecht, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of functional abdominal pain as defined by the Rome IV criteria for childhood functional gastrointestinal disorders

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up significant change from week-zero to week 12 between the active and placebo group

Awards & highlights

Study Summary

This trial will test whether psyllium, a dietary fiber, can reduce abdominal pain in children with functional abdominal pain, which is defined as recurrent abdominal pain independent of bowel movements without an underlying medical cause.

Eligible Conditions

Functional Abdominal Pain Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ significant change from week-zero to week 12 between the active and placebo group

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~significant change from week-zero to week 12 between the active and placebo group

This trial's timeline: 3 weeks for screening, Varies for treatment, and significant change from week-zero to week 12 between the active and placebo group for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in abdominal pain scores as measured by an abdominal pain diary

Secondary outcome measures

Anxiety scores as measured by PROMIS Anxiety scale

Quality of life as measured using the functional disability inventory (FDI)

Other outcome measures

Both structural and functional MRI will be used to quantify changes in connectivity between the amygdala and prefrontal cortex.

Respiratory sinus arrhythmia.This will be quantified using the high-frequency component of heart-rate variability.

Stool metabolome - Stool samples will be assayed using liquid chromatography-mass spectrometry for short-chain fatty acid levels

+1 more

Side effects data

From 2017 Phase 2 trial • 54 Patients • NCT03198767

83%

Diarrhea

25%

Constipation

Decreased appetite

Abdominal discomfort

Abdominal pain

Abdominal pain lower

Flatulence

Nausea

Back pain

Abdominal distension

100%

80%

60%

40%

20%

Study treatment Arm

Part A: LIK066 + 50% CHO

Part A: LIK066 + 25% CHO

Part A: LIK066 + 0% CHO

Part A: LIK066 + 8% CHO

Part B: LIK066 + 50% CHO + NS

Part B: LIK066 + 50% CHO + PS

Part B: LIK066 + 50% CHO CC

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PsylliumExperimental Treatment1 Intervention

For participants aged 8-11 and weighing > 24 kgs, the dosage is daily 3 grams for 2 weeks followed by daily 6 grams for 10 weeks. For children aged 12-16 and weighing > 40 kgs, the dosage is daily 5 grams for 2 weeks followed by daily 10 grams for 10 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psyllium

2015

Completed Phase 4

~720

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,734 Total Patients Enrolled

Alberta Children's Hospital Research InstituteOTHER

11 Previous Clinical Trials

7,207 Total Patients Enrolled

Gerald Giesbrecht, PhDPrincipal InvestigatorDepts. of Paediatrics and Community Health Sciences, University of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accommodate participants aged 18 and above?

"The parameters of this trial stipulate that participants must be between 8 and 16 years old. In addition, there are 11 clinical trials for minors and 13 studies exclusively recruiting adults aged 65 or older."

Answered by AI

What sort of qualifications must applicants meet to participate in this experiment?

"This clinical trial has a sample size of 40, and those interested must suffer from abdominal pain while also being aged between 8 to 16."

Answered by AI

Are there any vacancies available in this trial for potential participants?

"According to clinicaltrials.gov, the trial is not recruiting any more participants at this time; its initial posting date was June 1st 2022 and its most recent update given on May 16th 2022. Nonetheless, there are 23 other medical studies actively looking for patients presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Pain and Anxiety Through Dietary Fiber Supplementation in Children With Abdominal Pain

2022. "Reducing Pain and Anxiety Through Dietary Fiber Supplementation in Children With Abdominal Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04619095.