IBS - Irritable Bowel SyndromeNCT05721742
Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway
A study testing virtually administered dietitian consults for IBS patients. and IBS Group Online Session in people with IBS - Irritable Bowel Syndrome, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Irritable bowel syndrome is a functional bowel disorder that affects many Canadians. The syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- virtually administered dietitian consults for IBS patients. and IBS Group Online Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2023to 4 Sep 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent abdominal pain on average at least 1 day/ week in the last 3 months associated with two or more of the following criteria: related to defecation, or association with a change in frequency of stool or associated with a change in form (appearance) of stool
- Willingness to change diet
- Access to a device for accessing virtual dietary education
Who cannot join
- New onset symptoms within past year in age 50 and above
- Rectal bleeding
- Inflammatory Bowel Disease
- Unexplained recent weight loss
- Gastrointestinal surgery with removal of gallbladder or segments of the bowel
- Having an eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Irritable bowel syndrome is a functional bowel disorder that affects many Canadians. The syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. Primary care physicians are dissatisfied with current referral processes, and patients may wait a long time to receive the correct diagnosis. Diet is known to exacerbate symptoms of IBS. In Canada, accessing dietary treatment for IBS is a challenge due to lack of resources. Some patients lack access to dietary interventions, and others are given advice that is not evidenced based. Use of eHealth technology, such as virtual education delivered by a dietician, may allow for more widespread access to dietary interventions for IBS. Virtual education can include one on one dietary education, online group-based education, and the use of apps. Currently, there is a gap in knowledge whether dietary intervention for IBS, delivered virtually by a dietician, is effective in treating IBS.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- virtually administered dietitian consults for IBS patients., IBS Group Online Session
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtually administered dietitian consults for IBS patients.Other
Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS.
IBS Group Online SessionOther
IBS online group session run by Happy Bellies Nutrition
| Study group | Role | What they receive |
|---|---|---|
| pre-existing online group education program for IBS | Active comparator | This arm will be enrolled in the online course run by Happy Bellies Nutrition https://www.happybelliesnutrition.com/ibs-gentle-group-program. The Happy Bellies nutrition course has 5.5 hours of total video content and optional biweekly group calls via Zoom (45-minutes per session). This course is designed to take 12 weeks to complete. The participants would have access to the content for one year. Receives: Other: IBS Group Online Session |
| virtual dietitian consults for IBS patients | Experimental | This arm will receive consults with a virtual dietitian (60 minutes initial + 4 x30-minute follow-up appointment) by a dietitian who has had additional training in the dietary management of IBS. Receives: Other: virtually administered dietitian consults for IBS patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Symptom Severity
IBS Symptom Severity as measured by the "IBS Symptom Severity Score". Minimum: 75, Maximum: >300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300 respectively.
Measured: Baseline
IBS Symptom Severity
IBS Symptom Severity as measured by the "IBS Symptom Severity Score". Minimum: 75, Maximum: >300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300 respectively.
Measured: 5 months post-randomization
IBS Specific Quality of Life
IBS Specific Quality of Life as measured by the "IBS Quality of Life Questionnaire". Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life.
Measured: Baseline
IBS Specific Quality of Life
IBS Specific Quality of Life as measured by the "IBS Quality of Life Questionnaire". Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life.
Measured: 5 months post-randomization
Patient Quality of Life
Patient Quality of Life as measured by the "EQ 5D 5L Questionnaire". This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health.
Measured: Baseline
Patient Quality of Life
Patient Quality of Life as measured by the "EQ 5D 5L Questionnaire". This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health.
Measured: 5 months post-randomization
Total number Inpatient services in the last 3 months
Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Measured: Baseline
Total number Inpatient services in the last 3 months
Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Measured: 5 months post randomization
Total number Outpatient appointments in the last 3 months
Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Measured: baseline
Total number Outpatient appointments in the last 3 months
Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Measured: 5 months post randomization
Volume of referrals to Dietician
Volume of referrals sent to the Virtual Dietician led 1 on 1 education session
Measured: 5 months post-randomization
Volume of referrals to Online Group Session
Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition
Measured: 5 months post-randomization
Patient satisfaction with the Virtual Dietician led 1 on 1 education session
Patient satisfaction with the Virtual Dietician led 1 on 1 education session measured via questionnaires that were written by the study PI. The following statements will be presented, answers will follow a 5-point Likert scale where 1-strongly disagree 2-disagree 3-neutral 4-agree 5-strongly agree:
- I feel confident managing my IBS
- Overall, I was satisfied receiving dietary education through telehealth
- It was easy to ask questions and get answers
- I felt comfortable communicating with the dietitian using the telehealth system
- It was easy to use the technology to access the services
- I had no concerns about the privacy of my personal data
- I would recommend this service to friends and family
Measured: 5 weeks post-randomization
Volume of 1 on 1 dietary consults completed
Volume of 1 on 1 dietary consults completed, records kept by study dieticians
Measured: 5 months post-randomization
Number of online modules competed for Online Group Session
Number of online modules competed for Online Group Session
Measured: 5 months post-randomization
Number of sessions compared to proposed
Number of virtual dietician led 1 on 1 education sessions compared to proposed
Measured: 5 months post-randomization
Number of Modules accessed
Number of Modules accessed for Online group session program run by Happy Bellies Nutrition
Measured: 5 months post-randomization
Number of Modules completed
Number of Modules completed for Online group session program run by Happy Bellies Nutrition
Measured: 5 months post-randomization
Percentage participation in group session
Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed
Measured: 5 months post-randomization
Quality Adjusted Life Years
Quality adjusted life years as measured using the EQ 5D and client service receipt inventory
Measured: 5 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start16 May 2023
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Research Nova Scotia
- Responsible party
- Principal investigator, Jennifer Jones, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721742
- Sponsor's protocol ID
- 53363
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway
- ClinicalTrials.gov ID
- NCT05721742
- Acronym / sponsor ID
- 53363
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Research Nova Scotia
- Study start
- 16 May 2023 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 10 Feb 2023 (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.
Irritable bowel syndrome is a functional bowel disorder that affects many Canadians. The syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. Primary care physicians are dissatisfied with current referral processes, and patients may wait a long time to receive the correct diagnosis. Diet is known to exacerbate symptoms of IBS. In Canada, accessing dietary treatment for IBS is a challenge due to lack of resources. Some patients lack access to dietary interventions, and others are given advice that is not evidenced based. Use of eHealth technology, such as virtual education delivered by a dietician, may allow for more widespread access to dietary interventions for IBS. Virtual education can include one on one dietary education, online group-based education, and the use of apps. Currently, there is a gap in knowledge whether dietary intervention for IBS, delivered virtually by a dietician, is effective in treating IBS.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-existing online group education program for IBS | Active comparator | Other: IBS Group Online SessionThis arm will be enrolled in the online course run by Happy Bellies Nutrition https://www.happybelliesnutrition.com/ibs-gentle-group-program. The Happy Bellies nutrition course has 5.5 hours of total video content and optional biweekly group calls via Zoom (45-minutes per session). This course is designed to take 12 weeks to complete. The participants would have access to the content for one year. |
| virtual dietitian consults for IBS patients | Experimental | Other: virtually administered dietitian consults for IBS patients.This arm will receive consults with a virtual dietitian (60 minutes initial + 4 x30-minute follow-up appointment) by a dietitian who has had additional training in the dietary management of IBS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent abdominal pain on average at least 1 day/ week in the last 3 months associated with two or more of the following criteria: related to defecation, or association with a change in frequency of stool or associated with a change in form (appearance) of stool
- Willingness to change diet
- Access to a device for accessing virtual dietary education
Key exclusion criteria (6 listed)
- New onset symptoms within past year in age 50 and above
- Rectal bleeding
- Inflammatory Bowel Disease
- Unexplained recent weight loss
- Gastrointestinal surgery with removal of gallbladder or segments of the bowel
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 |
|---|---|---|
| virtually administered dietitian consults for IBS patients.Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS. | Other | virtual dietitian consults for IBS patients |
| IBS Group Online SessionIBS online group session run by Happy Bellies Nutrition | Other | pre-existing online group education program for IBS |
Primary outcome
IBS Symptom Severity
Time frame: Baseline
IBS Symptom Severity as measured by the "IBS Symptom Severity Score". Minimum: 75, Maximum: >300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300 respectively.
IBS Symptom Severity
Time frame: 5 months post-randomization
IBS Symptom Severity as measured by the "IBS Symptom Severity Score". Minimum: 75, Maximum: >300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300 respectively.
IBS Specific Quality of Life
Time frame: Baseline
IBS Specific Quality of Life as measured by the "IBS Quality of Life Questionnaire". Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life.
IBS Specific Quality of Life
Time frame: 5 months post-randomization
IBS Specific Quality of Life as measured by the "IBS Quality of Life Questionnaire". Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life.
Patient Quality of Life
Time frame: Baseline
Patient Quality of Life as measured by the "EQ 5D 5L Questionnaire". This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health.
Patient Quality of Life
Time frame: 5 months post-randomization
Patient Quality of Life as measured by the "EQ 5D 5L Questionnaire". This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health.
Total number Inpatient services in the last 3 months
Time frame: Baseline
Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Total number Inpatient services in the last 3 months
Time frame: 5 months post randomization
Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Total number Outpatient appointments in the last 3 months
Time frame: baseline
Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Total number Outpatient appointments in the last 3 months
Time frame: 5 months post randomization
Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.
Volume of referrals to Dietician
Time frame: 5 months post-randomization
Volume of referrals sent to the Virtual Dietician led 1 on 1 education session
Volume of referrals to Online Group Session
Time frame: 5 months post-randomization
Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition
Patient satisfaction with the Virtual Dietician led 1 on 1 education session
Time frame: 5 weeks post-randomization
Patient satisfaction with the Virtual Dietician led 1 on 1 education session measured via questionnaires that were written by the study PI. The following statements will be presented, answers will follow a 5-point Likert scale where 1-strongly disagree 2-disagree 3-neutral 4-agree 5-strongly agree: 1. I feel confident managing my IBS 2. Overall, I was satisfied receiving dietary education through telehealth 3. It was easy to ask questions and get answers 4. I felt comfortable communicating with the dietitian using the telehealth system 5. It was easy to use the technology to access the services 6. I had no concerns about the privacy of my personal data 7. I would recommend this service to friends and family
Volume of 1 on 1 dietary consults completed
Time frame: 5 months post-randomization
Volume of 1 on 1 dietary consults completed, records kept by study dieticians
Number of online modules competed for Online Group Session
Time frame: 5 months post-randomization
Number of online modules competed for Online Group Session
Number of sessions compared to proposed
Time frame: 5 months post-randomization
Number of virtual dietician led 1 on 1 education sessions compared to proposed
Number of Modules accessed
Time frame: 5 months post-randomization
Number of Modules accessed for Online group session program run by Happy Bellies Nutrition
Number of Modules completed
Time frame: 5 months post-randomization
Number of Modules completed for Online group session program run by Happy Bellies Nutrition
Percentage participation in group session
Time frame: 5 months post-randomization
Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed
Quality Adjusted Life Years
Time frame: 5 months post-randomization
Quality adjusted life years as measured using the EQ 5D and client service receipt inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtually administered dietitian consults for IBS patients. and IBS Group Online Session in people with IBS - Irritable Bowel Syndrome, run by Nova Scotia Health Authority 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Sep 2026. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IBS Symptom Severity (time frame: Baseline). The study lists 20 primary outcomes in all. 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 9 Sep 2026.