NCT05721742

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

February 1, 2023

Last Update Submit

July 8, 2025

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (20)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    5 months post randomization

  • Volume of referrals to Dietician

    Volume of referrals sent to the Virtual Dietician led 1 on 1 education session

    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

    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: 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

    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

    5 months post-randomization

  • Number of online modules competed for Online Group Session

    Number of online modules competed for Online Group Session

    5 months post-randomization

  • Number of sessions compared to proposed

    Number of virtual dietician led 1 on 1 education sessions compared to proposed

    5 months post-randomization

  • Number of Modules accessed

    Number of Modules accessed for Online group session program run by Happy Bellies Nutrition

    5 months post-randomization

  • Number of Modules completed

    Number of Modules completed for Online group session program run by Happy Bellies Nutrition

    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

    5 months post-randomization

  • Quality Adjusted Life Years

    Quality adjusted life years as measured using the EQ 5D and client service receipt inventory

    5 months post-randomization

Study Arms (2)

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.

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.

Other: virtually administered dietitian consults for IBS patients.

Interventions

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.

virtual dietitian consults for IBS patients
IBS Group Online SessionOTHER

IBS online group session run by Happy Bellies Nutrition

pre-existing online group education program for IBS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, N.S., B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

May 16, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)