Functional Abdominal Pain SyndromeNCT04619095
Reducing Pain and Anxiety Through Dietary Fiber Supplementation in Children With Abdominal Pain
A study testing Psyllium in people with Functional Abdominal Pain Syndrome, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- Psyllium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of functional abdominal pain as defined by the Rome IV criteria for childhood functional gastrointestinal disorders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pediatric GI Motility Laboratory at Alberta Children's Hospital
Calgary, Alberta
About this study
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.
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.
Read more
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.
- Conditions
- Functional Abdominal Pain Syndrome
- Being tested
- Psyllium, Placebo
- Keywords
- Fiber, Psyllium, Quality of life, Gut microbiota, Anxiety, Pediatrics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
See the information already included in the arm descriptions.
PlaceboDietary supplement
See the information already included in the arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Experimental | 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. Receives: Dietary Supplement: Psyllium |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal pain scores as measured by an abdominal pain diary
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
Measured: Significant change from week-zero to week 12 between the active and placebo group
Secondary outcomes (2)
Anxiety scores as measured by PROMIS Anxiety scale
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.
Measured: Significant change from week-zero to week 12 between the active and placebo group
Quality of life as measured using the functional disability inventory (FDI)
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.
Measured: Significant change from week-zero to week 12 between the active and placebo group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jun 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Why it stopped: We were unable to recruit any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Gerald Giesbrecht, PhD, Principal investigator, Depts. of Paediatrics and Community Health Sciences, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619095
- Sponsor's protocol ID
- REB20-1373
- Status last verified
- Sep 2021
- First submitted
- 2 Oct 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04619095
- Acronym / sponsor ID
- REB20-1373
- Conditions
- Functional Abdominal Pain Syndrome
- Keywords
- Fiber, Psyllium, Quality of life, Gut microbiota, Anxiety, Pediatrics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to recruit any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital Research Institute
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 6 Nov 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psyllium | Experimental | Dietary Supplement: PsylliumFor 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFor 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of functional abdominal pain as defined by the Rome IV criteria for childhood functional gastrointestinal disorders
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PsylliumSee the information already included in the arm descriptions. | Dietary supplement | Psyllium |
| PlaceboSee the information already included in the arm descriptions. | Dietary supplement | Placebo |
Primary outcome
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
2 secondary outcomes
Anxiety scores as measured by PROMIS Anxiety scale
Time frame: Significant change from week-zero to week 12 between the active and placebo group
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gerald Giesbrecht, PhD principal investigator
Depts. of Paediatrics and Community Health Sciences, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium in people with Functional Abdominal Pain Syndrome, run by University of Calgary at 1 site in Canada.
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: withdrawn, as of the sponsor's last update on 26 Jan 2023. 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 Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 Jan 2023.