What side effects are associated with this type of intervention?

Common treatments for gastrointestinal disorders include antispasmodics, tricyclic antidepressants, bile acid sequestrants, and antidiarrheals. Antispasmodics, such as dicyclomine and hyoscyamine, can cause dry mouth, dizziness, and blurred vision. Tricyclic antidepressants, like amitriptyline, may lead to drowsiness, weight gain, and constipation. Bile acid sequestrants, such as cholestyramine and colesevelam, often result in gastrointestinal side effects like constipation, nausea, and bloating. Antidiarrheals, including loperamide, can cause constipation and, in rare cases, abdominal pain or bloating. These side effects should be discussed with a healthcare provider to ensure appropriate management.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gastrointestinal disorders, particularly those similar to the treatments being studied in the Clinical Care Pathway trial. For irritable bowel syndrome (IBS), antispasmodics like dicyclomine and hyoscyamine are commonly used, along with antidepressants such as amitriptyline for persistent abdominal pain. For Crohn's disease and ulcerative colitis, biologic agents like anti-tumor necrosis factor (TNF) agents and small molecules like tofacitinib have been approved. Additionally, bile acid sequestrants such as cholestyramine and colesevelam are used for managing diarrhea in these conditions. These treatments are part of structured guidelines aimed at improving patient outcomes through evidence-based protocols.

What other types of research exist?

Promising novel alternatives to Clinical Care Pathways for gastrointestinal disorder patients in 2024 include: 1) Telemedicine and remote monitoring, which allow for continuous patient management and timely interventions without frequent clinic visits. 2) Artificial Intelligence (AI) and machine learning algorithms to personalize treatment plans based on patient-specific data and predictive analytics. 3) Integration of wearable health technology to monitor real-time physiological parameters and detect early signs of complications. 4) Use of microbiome-based therapies, including personalized probiotics and fecal microbiota transplantation, to manage and treat gastrointestinal disorders. 5) Implementation of virtual reality (VR) and augmented reality (AR) for patient education and procedural training, enhancing patient understanding and compliance with treatment protocols.

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GUT LINK SmartPath for Irritable Bowel Syndrome

N/A

Recruiting

Research Sponsored by Michael Stewart

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study involves the implementation of a care pathway rather than medication, traditional side effects are not applicable. However, there may be challenges or changes in practice management.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of clicks per referral

Number of referrals

Number of referrals per user

+3 more

Secondary study objectives

Number of referrals aborted

Number of referrals received requiring troubleshooting

Number referrals received as per prototype

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastrointestinal disorders work through various mechanisms to alleviate symptoms. Selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants help by modulating pain perception and improving mood, which can be beneficial for patients with chronic abdominal pain and overlapping symptoms of depression. Antispasmodics, such as dicyclomine and hyoscyamine, reduce muscle spasms in the gut, providing relief from abdominal pain and discomfort. Fiber supplements like psyllium improve bowel regularity and stool consistency, which is crucial for managing constipation-predominant symptoms. Polyethylene glycol (PEG) acts as an osmotic laxative, drawing water into the bowel to ease constipation. Bile acid sequestrants, such as cholestyramine, bind bile acids in the intestine, reducing diarrhea in patients with bile acid malabsorption. These treatments are essential as they target specific symptoms, improving the quality of life for patients with gastrointestinal disorders.

Future aspects of functional gastrointestinal disease: how should treatments be evaluated.