GUT LINK SmartPath for Irritable Bowel Syndrome
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Michael Stewart
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial aims to test a new set of guidelines to help doctors better diagnose and treat patients with digestive issues like IBS. The goal is to make it easier for primary care doctors to manage these conditions without needing specialists or invasive tests.
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 data supports the effectiveness of the GUT LINK SmartPath treatment for irritable bowel syndrome?
The research highlights that IBS treatment often involves a combination of therapies, including probiotics and serotonin receptor agents, which are similar to components that might be in GUT LINK SmartPath. These approaches have shown promise in managing IBS symptoms by addressing gut-brain communication and improving bowel function.12345
Is GUT LINK SmartPath safe for humans?
How is the GUT LINK SmartPath treatment different from other IBS treatments?
The GUT LINK SmartPath treatment for IBS is unique because it likely targets the gut-brain axis, addressing the hypersensitivity and hyperreactivity of the gastrointestinal tract, which are not typically the focus of conventional IBS treatments. This approach may offer a novel way to manage IBS symptoms by potentially modulating the complex interactions between the gut and the nervous system.18111213
Research Team
Eligibility Criteria
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
See 1 more
Exclusion Criteria
Not applicable.
Trial Timeline
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
Treatment Details
Interventions
- GUT LINK SmartPath (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: GUT LINK SmartPathExperimental Treatment1 Intervention
physicians will use the interactive GUT LINK Smartpath tool in virtual hallway platform to guide their care and referral practices
Group II: controlActive Control1 Intervention
physicians will provide care and refer as per their usual practices
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
QEII Health Sciences CentreHalifax, Canada
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Who Is Running the Clinical Trial?
Michael Stewart
Lead Sponsor
Trials
1
Patients Recruited
120+
Nova Scotia Health Authority
Collaborator
Trials
302
Patients Recruited
95,300+
Findings from Research
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]
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Pain therapy in irritable bowel syndrome].de Greck, M., Layer, P., Andresen, V.[2021]
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 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]
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]
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]
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Treatment of abdominal pain in irritable bowel syndrome.Vanuytsel, T., Tack, JF., Boeckxstaens, GE.[2021]
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) 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]
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]
References
Management of the irritable bowel syndrome. [2022]
Measuring successful treatment of irritable bowel syndrome: is "satisfactory relief " enough? [2019]
[Pain therapy in irritable bowel syndrome]. [2021]
What does the future hold for irritable bowel syndrome and the functional gastrointestinal disorders? [2019]
Definition and classification of irritable bowel syndrome: current consensus and controversies. [2009]
Adverse events appear to unblind clinical trials in irritable bowel syndrome. [2014]
Multi-target Treatment for Irritable Bowel Syndrome with STW 5: Pharmacological Modes of Action. [2021]
Irritable bowel syndrome: the evolution of multi-dimensional looking and multidisciplinary treatments. [2021]
Traditional therapies for irritable bowel syndrome: an evidence-based appraisal. [2005]
Treatment of abdominal pain in irritable bowel syndrome. [2021]
Hypersensitivity and hyperreactivity in the irritable bowel syndrome: An opportunity for drug discovery. [2017]
Centrally acting therapies for irritable bowel syndrome. [2022]
Genetic Variations in TrkB.T1 Isoform and Their Association with Somatic and Psychological Symptoms in Individuals with IBS. [2023]