What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome (IBS) include dietary modifications, fiber supplements, antispasmodics, and medications like lubiprostone and linaclotide. Dietary changes, such as a low FODMAP diet, can cause initial digestive discomfort. Fiber supplements may lead to bloating and gas. Antispasmodics can cause dry mouth, dizziness, and constipation. Antidepressants, used for persistent pain, may result in weight gain, drowsiness, and sexual dysfunction. Lubiprostone and linaclotide, used for constipation-predominant IBS, often cause nausea and diarrhea. These side effects should be discussed with a healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Irritable Bowel Syndrome (IBS), particularly for IBS with diarrhea (IBS-D). Alosetron (Lotronex) is a 5-HT3 receptor antagonist approved for women with severe IBS-D, shown to improve symptoms like urgency and abdominal pain but associated with a higher risk of constipation. Eluxadoline (Viberzi) is another drug approved for IBS-D, which reduces abdominal pain and improves stool consistency but can cause nausea, constipation, and, in rare cases, pancreatitis. Rifaximin, an antibiotic, is approved for IBS without constipation, particularly for patients with bloating, and has shown modest benefits in clinical trials. These treatments align with the REACH Program's goal of managing IBS symptoms and improving quality of life through targeted interventions.

What other types of research exist?

Promising alternatives to the REACH Program Websites for IBS patients in 2024 include: 1) Constant-care web applications for self-management, which have shown feasibility in improving disease outcomes. 2) Dietary modifications such as the low FODMAP diet and gluten-free diet, which are gaining traction for symptom management. 3) Emerging pharmacologic treatments tailored to specific IBS symptoms, such as lubiprostone and linaclotide for constipation, and antispasmodics or bile acid sequestrants for diarrhea. 4) Future therapies like fecal transplantation and personalized medicine approaches, which are under research for their potential benefits.

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Behavioral Intervention

Social Learning and Cognitive Behavioral Therapy for Irritable Bowel Syndrome (REACH Trial)

N/A

Recruiting

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Summary

This trial tests if using specific websites can help parents with IBS teach their young children healthy habits. The goal is to reduce the risk of children developing stomach pain by improving how parents manage stress and support their kids. The study involves parents using one of two websites focused on child health or wellness.

Who is the study for?

This trial is for parents over 18 with IBS who are the main caregivers of a child aged 4-6. The parent must meet ROME criteria for IBS, have been diagnosed within the last five years, and their child should live with them at least half the time. It's not for those who can't understand English, whose children have certain gastrointestinal disorders or severe chronic diseases, or lack regular internet access.

What is being tested?

The REACH program's effectiveness is being tested to see if it helps parents with IBS teach their kids healthy habits. Participants will use one of two websites: one on child health/safety and another on promoting wellness behaviors. They're randomly assigned to either site and asked to complete online surveys.

What are the potential side effects?

Since this trial involves educational programs delivered via websites without medical interventions, there are no direct physical side effects expected from participation in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in parental encouragement of child illness behavior

Secondary study objectives

Change in abdominal pain symptoms

Change in anxiety

Change in depressive symptoms

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Social Learning and Cognitive Behavioral Therapy (SLCBT)Experimental Treatment1 Intervention

Group II: Attention Education ControlPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Social Learning and Cognitive Behavioral Therapy (SLCBT)

2003

Completed Phase 2

~200

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 Irritable Bowel Syndrome (IBS) include dietary modifications, pharmacologic therapies, and psychological interventions. The low FODMAP diet reduces symptoms by eliminating fermentable carbohydrates that cause bloating and pain. Antispasmodics help by relaxing the muscles of the gastrointestinal tract, reducing pain and cramping. Antidiarrheals decrease stool frequency and urgency, while bile acid sequestrants bind bile acids to reduce diarrhea. Psychological interventions, such as cognitive-behavioral therapy, address the brain-gut interaction, helping to manage stress and anxiety that can exacerbate IBS symptoms. These treatments are crucial as they target different aspects of IBS, providing a comprehensive approach to symptom management and improving the quality of life for patients.