Virtual Dietitian Consults for Irritable Bowel Syndrome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Inflammatory bowel disease, Rectal bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual sessions with a dietitian can help manage irritable bowel syndrome (IBS), a condition causing stomach pain and changes in bowel habits. Participants will either receive one-on-one virtual dietitian consults or join an online group education program. The goal is to determine if these virtual dietary interventions, known as Virtual Dietary Education, can improve IBS symptoms. This trial suits individuals with frequent stomach pain related to bowel movements, who are open to dietary changes and can access online resources. As an unphased trial, it offers a unique opportunity to explore innovative dietary interventions for IBS management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dietary changes for managing IBS.

What prior data suggests that virtual dietary education is safe for IBS patients?

Research has shown that virtual dietary education is generally safe for people with irritable bowel syndrome (IBS). Studies indicate that patients often find virtual group sessions and webinars both acceptable and effective. Participants in these studies did not report any major safety concerns with the virtual format.

Evidence also suggests that virtual education can reduce the need for in-person appointments without causing harm, indicating that the treatment is well-tolerated. While the studies focus on effectiveness, they do not mention any significant negative effects, which is a positive sign for safety. Overall, virtual consultations for managing IBS diets appear to be a safe option for those considering this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Virtual dietitian consults for IBS are unique because they offer a personalized and flexible approach to dietary management. Unlike traditional in-person appointments, these consults can be done from the comfort of your home, making them more accessible and convenient. The virtual format allows for tailored advice from a dietitian specially trained in IBS, ensuring that dietary recommendations are specific to each individual's needs. Researchers are excited about this trial as it could demonstrate the effectiveness of remote consultations, potentially transforming dietary management for IBS patients by making it more convenient and personalized.

What evidence suggests that virtual dietary education is effective for irritable bowel syndrome?

Research has shown that online dietary education can help manage irritable bowel syndrome (IBS). In this trial, participants will divide into two groups. One group will receive virtual dietitian consults, involving personalized sessions with a dietitian trained in IBS dietary management. Studies have found that virtual group sessions effectively provide dietary advice. Another study found that educational webinars for IBS patients led to fewer one-on-one clinic visits, suggesting better patient outcomes. Additionally, diets like the Mediterranean diet have reduced IBS symptoms such as stomach pain and bloating. These findings support the benefits of virtual consultations with dietitians for people with IBS. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Irritable Bowel Syndrome (IBS) who have regular abdominal pain and changes in bowel habits. Participants need to have access to a device for virtual dietary education and be willing to change their diet.

Inclusion Criteria

You can access a device to attend online nutrition classes.

I have had stomach pain at least once a week for the last 3 months, which changes with my bowel movements.

You are okay with changing your diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual dietary education through either one-on-one consults with a dietitian or an online group education program

12 weeks

1 initial visit (virtual, 60 minutes) + 4 follow-up visits (virtual, 30 minutes each) for one-on-one consults; biweekly group calls (virtual, 45 minutes each) for group program

Follow-up

Participants are monitored for effectiveness of dietary interventions and quality of life improvements

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Dietary Education

Trial Overview The study tests if IBS symptoms can be improved through virtual dietary education provided by dietitians. This includes one-on-one consultations, online group sessions, and possibly app-based support.

How Is the Trial Designed?

Group I: virtual dietitian consults for IBS patients Experimental Treatment 1 Intervention

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.

Group II: pre-existing online group education program for IBS Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Research Nova Scotia

Collaborator

Trials

3

Recruited

600+

Published Research Related to This Trial

A study involving 1171 attendees showed that webinars for IBS education significantly improved patients' knowledge (from 25% to 67% reporting excellent or good knowledge) and confidence in managing their condition (74% reported improved confidence).

The implementation of these webinars resulted in a 44% reduction in referrals for one-on-one dietitian appointments, saving an estimated £3593 in clinical time costs annually, making it a cost-effective solution for patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and cost efficiency of using webinars to deliver first-line patient education for people with Irritable Bowel Syndrome as part of a dietetic-led gastroenterology service in primary care. Williams, M., Barclay, Y., Harper, L., et al.[2021]

The study highlights that diet is crucial for managing irritable bowel syndrome (IBS), and many patients turn to the Internet for dietary advice.

However, the research found that online dietary recommendations for IBS often lack quality and accuracy, which can mislead patients seeking reliable information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Quality and Readability of Internet Dietary Information on Irritable Bowel Syndrome. Alfaro-Cruz, L., Kaul, I., Zhang, Y., et al.[2020]

A survey of 279 gastroenterology providers revealed that while 56% feel trained to provide nutrition education for IBS, nearly half do not offer practical dietary guidance, indicating a significant gap in patient care.

Despite the majority (91%) agreeing that access to a GI dietitian would enhance IBS management, 42% of providers reported lacking access to such specialists, highlighting a barrier to effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Dietitians in the Management of Irritable Bowel Syndrome by Members of the American College of Gastroenterology. Scarlata, K., Eswaran, S., Baker, JR., et al.[2022]

A survey of 1,242 IBS patients revealed that many hold misconceptions about the condition, such as believing it is caused by a lack of digestive enzymes or that it can develop into cancer, indicating a significant need for better patient education.

Patients expressed a strong interest in learning about dietary changes, causes of IBS, and coping strategies, highlighting the importance of targeted educational resources, especially for those who seek information online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What patients know about irritable bowel syndrome (IBS) and what they would like to know. National Survey on Patient Educational Needs in IBS and development and validation of the Patient Educational Needs Questionnaire (PEQ). Halpert, A., Dalton, CB., Palsson, O., et al.[2022]

In a large French cohort study of 41,682 participants, a stable vegetarian diet (VD) was found to be associated with an increased risk of irritable bowel syndrome (IBS) and its subtypes, particularly IBS mixed and IBS diarrhea.

While the overall analysis did not show a significant association between VD and IBS, those who adhered to a vegetarian diet consistently reported higher odds of developing IBS, suggesting that long-term dietary patterns may influence gastrointestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between self-reported vegetarian diet and the irritable bowel syndrome in the French NutriNet cohort. Buscail, C., Sabate, JM., Bouchoucha, M., et al.[2018]

The guidelines for managing Irritable Bowel Syndrome (IBS) emphasize a structured dietary approach, starting with clinical assessments and general healthy eating advice, followed by advanced interventions like probiotics and specific carbohydrate management.

A total of 30 studies were reviewed to create these evidence-based guidelines, highlighting the importance of tailored dietary strategies and the need for further research through well-designed clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

British Dietetic Association evidence-based guidelines for the dietary management of irritable bowel syndrome in adults. McKenzie, YA., Alder, A., Anderson, W., et al.[2022]

A survey of 1,562 gastroenterologists revealed that nearly 60% believe patients with irritable bowel syndrome (IBS) often link food to their gastrointestinal symptoms, and most recommend dietary therapy, particularly a low FODMAP diet.

Despite the enthusiasm for dietary treatments, only 21% of gastroenterologists regularly refer IBS patients to registered dietitians, indicating a gap in nutritional counseling for effective management of IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Dietary Management in Irritable Bowel Syndrome: Results of a Survey of Over 1500 United States Gastroenterologists. Lenhart, A., Ferch, C., Shaw, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05721742

Evaluating the Impact of Including Virtual Dietary Education ... Currently, there is a gap in knowledge whether dietary intervention for IBS, delivered virtually by a dietician, is effective in treating IBS. Official Title.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4047359/

Ehealth monitoring in irritable bowel syndrome patients ... In the present study we report on changes in irritable bowel syndrome-severity scoring system (IBS-SSS) and irritable bowel syndrome-quality of life ...

3. gut.bmj.com gut.bmj.com/content/73/Suppl_1/A287.1

are remote virtual group clinics the answer? Conclusions Our data and experience suggest that virtual group sessions are feasible, acceptable to patients, and clinically effective for delivering first-line ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jhn.12799

Feasibility, acceptability and cost efficiency of using ... Using irritable bowel syndrome (IBS) patient education webinars led to a 44% reduction in referrals for one-to-one appointments with a ...

5. mdpi.com mdpi.com/2077-0383/13/24/7531

Efficacy of Dietary Interventions for Irritable Bowel Syndrome Our results show the comparative effectiveness of the Mediterranean diet and LFD in alleviating IBS symptoms, particularly abdominal distention, and improving ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39899743/

The Effects of Digital eHealth Versus Onsite 2-Day Group ... We conclude that the digital multidisciplinary eHealth program has a significant effect on IBS symptom severity in a portion of patients; ...