GUT LINK SmartPath for Irritable Bowel Syndrome

Overseen By Natalie Willett, BSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Michael Stewart

Disqualifiers: Not a general practitioner, others

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called GUT LINK SmartPath to help doctors manage and treat irritable bowel syndrome (IBS) more effectively. Doctors often struggle to distinguish IBS from more serious gut issues like Crohn's disease or cancer. The trial aims to determine if this tool aids doctors in making better decisions and improving care for patients with stomach problems. Physicians practicing in Nova Scotia who use the 'virtual hallway' platform for patient referrals are well-suited for this trial.

As an unphased study, this trial offers patients the chance to contribute to innovative research that could enhance IBS diagnosis and treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the GUT LINK SmartPath is safe for use in clinical care pathways?

Research shows that current studies lack specific safety information for GUT LINK SmartPath. This treatment helps doctors manage and refer patients with irritable bowel syndrome (IBS). As this is an early-stage study, detailed safety data remains limited. However, treatments at this stage are generally considered safe enough for human testing. While detailed safety information is unavailable, the treatment is likely thought to be well-tolerated. Discuss any concerns about joining a clinical trial with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GUT LINK SmartPath for Irritable Bowel Syndrome (IBS) because it introduces a new, interactive tool for guiding care in a virtual setting. Unlike traditional IBS treatments that often focus on medication to manage symptoms, GUT LINK SmartPath leverages digital technology to enhance physician decision-making and patient referrals. This innovative approach could lead to more personalized and efficient care pathways, potentially improving patient outcomes by connecting them to the most appropriate treatments faster.

What evidence suggests that the GUT LINK SmartPath is effective for managing IBS?

Research has shown that guidelines for diagnosing and treating irritable bowel syndrome (IBS) exist, but they are not widely used in regular doctor visits. This trial tests the GUT LINK SmartPath, an experimental tool designed to help doctors better adhere to these guidelines. This tool can improve the diagnosis and treatment of digestive problems like IBS. While specific results on the effectiveness of GUT LINK SmartPath are not yet available, it aims to make healthcare more organized and efficient. This should assist doctors in making better decisions and enhance care for patients with IBS. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for general practitioners in Nova Scotia, Canada who use 'virtual hallway' for referrals and treat patients with lower GI complaints. It aims to improve the diagnosis and treatment of IBS by implementing a new care pathway.

Inclusion Criteria

Must be a general practitioner

Have a family practice in Nova Scotia, Canada

Utilize the platform 'virtual hallway' as part of current referral practices

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Clinical Care Pathway for lower GI tract symptoms

3 months

Evaluation

Evaluation of the effectiveness and acceptability of the GUT LINK SmartPath tool

3 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• GUT LINK SmartPath

Trial Overview The GUT LINK SmartPath is being tested as a Clinical Care Pathway to help primary healthcare providers better manage lower gastrointestinal tract symptoms and differentiate IBS from more serious conditions.

How Is the Trial Designed?

Group I: GUT LINK SmartPath Experimental Treatment 1 Intervention

physicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices

Group II: control Active Control 1 Intervention

physicians will provide care and refer as per their usual practices

Who Is Running the Clinical Trial?

Michael Stewart

Lead Sponsor

Trials

1

Recruited

120+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Published Research Related to This Trial

Irritable bowel syndrome (IBS) is a complex disorder with multiple causes, including gut dysmotility, visceral hypersensitivity, and imbalanced gut microbiota, which can lead to symptoms like pain and disturbed defecation.

First-line treatments for IBS include antispasmodics and stool consistency modifiers, while probiotics are considered safe options, and dietary changes can help manage symptoms; however, new drugs targeting bowel function may have serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome: the evolution of multi-dimensional looking and multidisciplinary treatments. Chang, FY.[2021]

Cognitive interventions like cognitive behavioral therapy and hypnotherapy show excellent results for treating functional abdominal pain in IBS, but their practical use is limited due to availability and the effort required.

Tricyclic antidepressants (TCAs) are effective for reducing abdominal pain in IBS, while a low FODMAP diet can help alleviate symptoms in some patients, highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of abdominal pain in irritable bowel syndrome. Vanuytsel, T., Tack, JF., Boeckxstaens, GE.[2021]

In clinical trials for irritable bowel syndrome (IBS), a higher incidence of adverse events (AEs) in patients receiving active treatment is linked to better reported outcomes, suggesting that AEs may influence patient perceptions of treatment efficacy.

The study found a significant correlation between the attributable drug benefit and the average risk difference of AEs between treatment and placebo groups, indicating that AEs could lead to unblinding and affect the perceived effectiveness of therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events appear to unblind clinical trials in irritable bowel syndrome. Shah, E., Triantafyllou, K., Hana, AA., et al.[2014]

Irritable bowel syndrome (IBS) involves hypersensitivity in the gastrointestinal tract, but the exact mechanisms behind this sensitivity are not well understood, complicating drug development.

Current research is focusing on pre-clinical and early-clinical approaches that target the gut-spinal cord/brain axis to reduce gastrointestinal hypersensitivity, aiming to guide the pharmaceutical industry in creating effective IBS treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypersensitivity and hyperreactivity in the irritable bowel syndrome: An opportunity for drug discovery. Sanger, GJ.[2017]

Irritable bowel syndrome (IBS) affects about 10% of people in industrialized countries and is influenced by a combination of psychosocial factors, altered gut motility, and heightened sensory function, indicating a complex biopsychosocial disorder.

Current treatments focus on symptom management, including fiber supplements for constipation and low-dose antidepressants for pain, while novel therapies like alosetron and tegaserod are being explored to better address challenging symptoms such as pain and bloating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of the irritable bowel syndrome. Camilleri, M.[2022]

Irritable bowel syndrome (IBS) is linked to dysregulation of the brain-gut axis, highlighting the importance of neurogastroenterology in understanding and treating this condition.

Centrally acting treatments can effectively alleviate pain and bowel dysfunction in IBS by targeting both the brain and gut, emphasizing the need for a comprehensive approach that considers the patient's perspective and psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centrally acting therapies for irritable bowel syndrome. Grover, M., Drossman, DA.[2022]

Current therapies for Irritable Bowel Syndrome (IBS), including traditional treatments like antidepressants and fiber supplements, as well as alternative therapies like peppermint oil and herbal supplements, lack sufficient evidence to support their effectiveness.

The review highlights that no IBS treatments can be reliably recommended due to inadequate high-quality studies demonstrating their efficacy, emphasizing the need for better-designed clinical trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional therapies for irritable bowel syndrome: an evidence-based appraisal. Fennerty, MB.[2005]

Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, with various subtypes based on symptoms, and its diagnosis should be thorough to reassure patients that it is a chronic but benign condition.

Treatment for IBS includes a range of options such as antispasmodics, probiotics, and specific medications like linaclotide for constipation and rifaximin for bloating, with an emphasis on managing abdominal pain and considering psychological factors in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain therapy in irritable bowel syndrome]. de Greck, M., Layer, P., Andresen, V.[2021]

The treatment options for irritable bowel syndrome (IBS) are increasing, with new therapies like probiotics and serotonin receptor agents being explored, but they require well-designed clinical trials to assess their effectiveness.

Current methods for measuring symptom improvement in IBS, such as asking patients if they experienced 'satisfactory relief,' may not accurately reflect their true symptom burden, suggesting a need for better measurement techniques, like assessing a 50% reduction in symptom severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring successful treatment of irritable bowel syndrome: is "satisfactory relief " enough? Schoenfeld, P., Talley, NJ.[2019]

Recent advancements in understanding irritable bowel syndrome (IBS) have shifted from solely focusing on motility issues to recognizing the importance of various factors such as visceral hypersensitivity, altered mucosal immunity, and brain-gut interactions, leading to improved diagnostic criteria and treatment approaches.

Future research aims to explore new neurotransmitters, the communication between the central and enteric nervous systems, and the impact of psychosocial factors on IBS symptoms, which could enhance treatment strategies combining pharmacological and behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What does the future hold for irritable bowel syndrome and the functional gastrointestinal disorders? Drossman, DA.[2019]

The symptom-based classification of IBS (Irritable Bowel Syndrome) is challenging, especially for non-English speakers, leading to potential misdiagnosis and inappropriate treatments, highlighting the need for better physician education on typical symptoms.

There is a call for more long-term studies on IBS symptoms and healthcare usage, as current understanding of the condition's pathophysiology may lead to more objective diagnoses and effective therapies in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and classification of irritable bowel syndrome: current consensus and controversies. Longstreth, GF.[2009]

In a study of 464 individuals with irritable bowel syndrome (IBS) and 156 healthy controls, a specific genetic variant (G/G genotype of rs2013566) was linked to worsened somatic symptoms and lower quality of life in IBS patients, including increased headaches and pain.

Several other genetic variants were associated with muscle pain in IBS patients, suggesting that variations in the TrkB.T1 isoform may play a role in the comorbid somatic and psychological symptoms experienced by these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Variations in TrkB.T1 Isoform and Their Association with Somatic and Psychological Symptoms in Individuals with IBS. Hong, H., Mocci, E., Kamp, K., et al.[2023]

Irritable bowel syndrome (IBS) affects about 11% of the global population and is characterized by various symptoms due to complex interactions between the gut and brain, necessitating multi-targeted treatment approaches.

STW 5, a herbal preparation with nine extracts, has shown efficacy in addressing multiple IBS-related mechanisms, including gastrointestinal motility, inflammation, and gut microbiota, making it a promising multi-targeted treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-target Treatment for Irritable Bowel Syndrome with STW 5: Pharmacological Modes of Action. Allescher, HD., Burgell, R., Malfertheiner, P., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-2-2023-3e7a8

GUT LINK SmartPath for Irritable Bowel Syndrome This trial aims to test a new set of guidelines to help doctors better diagnose and treat patients with digestive issues like IBS.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39830577/

Efficacy of Probiotics in the Management of Irritable Bowel ... Quality of life improved significantly, with a mean increase of 8.77 points (95% CI = 0.91 to 16.64, p = 0.028). Adverse events were mild and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5046167/

Irritable bowel syndrome, the microbiota and the gut-brain axis Intestinal permeability is increased 15–50% in patients with IBS meassured by expression in tight junction proteins. The increased permeability in IBS allows ...

4. clinicaltrial.be clinicaltrial.be/en/details/425681?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

GUT LINK: A Study of a Care Pathway Across Primary and ... To help with diagnosis and treatment of IBS, evidence-based guidelines have been developed. However, they are not commonly used in primary care ...

5. ctv.veeva.com ctv.veeva.com/study/gut-link-a-study-of-a-care-pathway-across-primary-and-gi-specialty-care

GUT LINK: A Study of a Care Pathway Across Primary and GI ... To help with diagnosis and treatment of IBS, evidence-based guidelines have been developed. However, they are not commonly used in primary care ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6039952/

The gut microbiome and irritable bowel syndrome - PMC Recent studies have demonstrated that an imbalance in gut bacterial communities, or “dysbiosis”, may be a contributor to the pathophysiology of IBS.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37653742/

Efficacy and safety of human gut-derived multi-strain ... The estimated response rate is 55%. Of 44 patients, the total IBS-SSS score responder rate was 18.2% and 63.6% of patients at 2 and 4 weeks, ...