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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04619095
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2020
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Alberta Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Calgary

Brief Summary:

Background - Mental health and pain problems in early childhood are major risk factors for serious mental health problems into adulthood. These long-term effects point toward the essential need for prevention and early intervention to curbing the rising tide of global mental health disease. New approaches to child and adolescent mental health are urgently needed.

This study focus on children with functional abdominal pain (FAP), which is defined as recurrent abdominal pain independent of bowel movements without an underlying medical cause. This population has a high co-occurrence of anxiety and somatic complaints. The effects of fiber on gastrointestinal pain have not yet been tested in this group. The investigators propose that supplementation with dietary fiber (psyllium) in children with FAP will promote SCFA production by the gut microbiota, reducing abdominal pain and subsequently anxiety and improving quality of life. Psyllium promotes SCFA production, is considered safe, and meta-analyses have identified it as the most potent fiber for reducing abdominal complaints in IBS patients, indicating strong potential for reducing abdominal pain in children with FAP.

It is essential that potential mechanisms through which psyllium-induced SCFA production can reduce abdominal pain and anxiety symptoms and improve quality of life are explored. This study will explore 3 mechanisms: 1) activation of the vagus nerve, as SCFAs can induce vagal signalling, and evidence suggests that vagus nerve stimulation can reduce pain and anxiety symptoms; 2) reduction in HPA-axis responsiveness, since fiber has been shown to do so in adults, and both abdominal pain and anxiety disorders are associated with increased HPA-axis activity; and 3) structural and functional brain changes in the amygdala and hippocampus, as SCFA can influence neuronal activity of specific brain regions and probiotics-induced improvements in mental health have been related to these brain regions in adults with IBS.

Research question & Objectives - The first objective is to provide a dietary fiber psyllium supplement to children (ages 8-16 years) who suffer from FAP. The aims are to: 1) determine whether psyllium reduces abdominal pain, 2) investigate whether this subsequently decreases anxiety and improves quality of life, and 3) assess associated gut-brain axis mediators, specifically the vagus nerve, HPA-axis, and brain networks.

Methods - The investigators propose a 12-week placebo-controlled double-blind parallel-group intervention pilot study (n=20/group) where children suffering from FAP will receive a daily supplement of either psyllium or placebo (maltodextrin). 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. An initial lower dose was chosen to allow the gastrointestinal tract to acclimatize to the increase in dietary fiber. The dosages were chosen based on the fact that this age group typically consumes 10g less dietary fiber than recommended. All study measures are collected prior to, and after the intervention. The primary measure is abdominal pain frequency and intensity during 7 consecutive days. Secondary measures include parent and child reported anxiety and quality of life. Stool samples are used to determine gut microbiota and SCFAs. MRI will be used to assess the role of brain regions implicated in pain and anxiety. Respiratory sinus arrhythmia during seated rest will be used to assess basal vagal tone.


Condition or disease Intervention/treatment Phase
Functional Abdominal Pain Syndrome Dietary Supplement: Psyllium Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Blinded, Parallel, Placebo-controlled Study to Evaluate Whether Supplementation of the Dietary Fiber Psyllium Can Reduce Abdominal Pain and Improve Quality of Life and Anxiety in Children With Abdominal Pain.
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psyllium
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.
Dietary Supplement: Psyllium
See the information already included in the arm descriptions.

Placebo Comparator: Placebo
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.
Dietary Supplement: Placebo
See the information already included in the arm descriptions.




Primary Outcome Measures :
  1. Change in abdominal pain scores as measured by an abdominal pain diary [ Time Frame: Significant change from week-zero to week 12 between the active and placebo group ]

    The score minimum on the scale is 0, the maximum is 20. Higher scores indicate a worse outcome.

    The abdominal pain score diary is adapted from: See et al., 2001 - DOI: 10.1023/a:1010793408132



Secondary Outcome Measures :
  1. Anxiety scores as measured by PROMIS Anxiety scale [ Time Frame: Significant change from week-zero to week 12 between the active and placebo group ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) questionaire will be used. The score minimum on the scale is 8, the maximum is 40. Higher scores indicate a worse outcome.

  2. Quality of life as measured using the functional disability inventory (FDI) [ Time Frame: Significant change from week-zero to week 12 between the active and placebo group ]
    The functional disability inventory (FDI) questionnaire will be used. The score minimum on the scale is 0, the maximum is 96. Higher scores indicate a worse outcome.


Other Outcome Measures:
  1. Stool microbiome - Stool samples will be assayed using metagenome shotgun sequencing, after which alpha diversity is assessed. [ Time Frame: Significant change in alpha diversity from week-zero to week 12 between the active and placebo group ]
    Alpha diversity will be assessed using the Shannon diversity index.

  2. Stool metabolome - Stool samples will be assayed using liquid chromatography-mass spectrometry for short-chain fatty acid levels [ Time Frame: Significant change in short-chain fatty acid levels from week-zero to week 12 between the active and placebo group ]
    Short-chain fatty acid levels are expressed as mM.

  3. Respiratory sinus arrhythmia.This will be quantified using the high-frequency component of heart-rate variability. [ Time Frame: Significant change from week-zero to week 12 between the active and placebo group ]
    Vagus nerve activity will be measured indirectly using respiratory sinus arrhythmia.

  4. Both structural and functional MRI will be used to quantify changes in connectivity between the amygdala and prefrontal cortex. [ Time Frame: Significant change in amygdala-prefrontal cortex connectivity from week-zero to week 12 between the active and placebo group ]
    Connectivity will be expressed as a z-score.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosis of inflammatory bowel disease or irritable bowel syndrome
  • Lactose intolerance
  • Abdominal surgery within the past year
  • Contraindications for imaging
  • Antibiotic use over the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619095


Locations
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Canada, Alberta
Pediatric GI Motility Laboratory at Alberta Children's Hospital
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Alberta Children's Hospital Research Institute
Investigators
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Principal Investigator: Gerald Giesbrecht, PhD Depts. of Paediatrics and Community Health Sciences, University of Calgary
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04619095    
Other Study ID Numbers: REB20-1373
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Fiber
Psyllium
Quality of life
Gut microbiota
Anxiety
Pediatrics
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Psyllium
Cathartics
Gastrointestinal Agents