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Recruiting NCT05721742

Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway

No phase Interventional IBS - Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtually administered dietitian consults for IBS patients., IBS Group Online Session.
Who it may be relevant to
Registry conditions: IBS - Irritable Bowel Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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 IBS Group Online Session
    IBS online group session run by Happy Bellies Nutrition

Primary outcome measures

  • IBS Symptom Severity [Time frame: Baseline]
  • IBS Symptom Severity [Time frame: 5 months post-randomization]
  • IBS Specific Quality of Life [Time frame: Baseline]
  • IBS Specific Quality of Life [Time frame: 5 months post-randomization]
  • Patient Quality of Life [Time frame: Baseline]
  • Patient Quality of Life [Time frame: 5 months post-randomization]
  • Total number Inpatient services in the last 3 months [Time frame: Baseline]
  • Total number Inpatient services in the last 3 months [Time frame: 5 months post randomization]
  • Total number Outpatient appointments in the last 3 months [Time frame: baseline]
  • Total number Outpatient appointments in the last 3 months [Time frame: 5 months post randomization]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • QEII Health Sciences Centre — Halifax

Identifiers

NCT: NCT05721742 · 53363

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗