IBS-PPSM for Irritable Bowel Syndrome

(OIME Trial)

Overseen By Hugo F Posada-Quintero

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Must not be taking: Opioids, Illicit substances

Disqualifiers: Chronic pains, Celiac, Diabetes, 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 aims to better understand and manage pain in people with Irritable Bowel Syndrome (IBS). Researchers will evaluate the effectiveness of a new educational and self-management program, called the IBS-PPSM intervention, in reducing IBS-related pain. Participants will use an abdominal belt and smartwatch to record pain and other biosignals daily. Individuals with IBS who regularly experience abdominal pain may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative IBS pain management strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, regular use of opioids or other illicit substances is not allowed.

What prior data suggests that the IBS-PPSM intervention is safe for IBS participants?

Research shows that self-management treatments for IBS, such as the IBS-PPSM program, are generally easy for people to handle. Studies have found that these programs can improve IBS symptoms without causing major side effects. For instance, one study found that 76.7% of participants felt better using self-management techniques, and after 8 months, 83% of them still noticed improvements.

Another study highlighted the safety of non-drug treatments for IBS. These treatments helped with symptoms and were recommended for their safety and effectiveness.

Overall, this evidence suggests that the IBS-PPSM program is likely safe, as it employs self-management strategies that have been well-studied. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for irritable bowel syndrome (IBS), which often involve medications like antispasmodics, laxatives, or dietary changes, IBS-PPSM is a comprehensive self-management program. This intervention is unique because it combines educational video modules with personalized nurse consultations, focusing on self-monitoring and lifestyle adjustments, such as diet and sleep. Additionally, it incorporates the use of an abdominal belt and smartwatch system to track bio-signals and visceral pain episodes daily. Researchers are excited about this approach because it empowers patients to actively manage their symptoms and provides real-time data to potentially uncover more personalized insights into IBS management.

What evidence suggests that the IBS-PPSM intervention could be effective for treating IBS?

Research shows that IBS-PPSM is designed to help individuals with Irritable Bowel Syndrome (IBS) manage their condition independently. Participants in the IBS-PPSM intervention group will receive educational video modules and personalized consultations to manage IBS symptoms. Past participants have found that learning about IBS and adjusting lifestyle factors like diet and sleep can ease symptoms. Similar studies have shown that cognitive-behavioral therapy (a type of talk therapy) helped most people feel significantly better, with up to 62% reporting a substantial improvement in their IBS symptoms. The goal is for IBS-PPSM to reduce pain and discomfort by enhancing understanding and management of the condition. However, specific data on IBS-PPSM's effectiveness is still being collected, so while results appear promising, they are not yet final. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with Irritable Bowel Syndrome (IBS) according to Rome-III or -IV criteria, who experience abdominal pain. Participants must have daily access to a computer with internet.

Inclusion Criteria

I have daily access to a computer with internet.

I have been diagnosed with IBS and currently experience abdominal pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection and Training

Data collection for training the OIME model, collecting autonomic and muscular activities with integrated biosignal device and visceral pain level in both healthy controls and IBS participants.

4 weeks

Baseline visit

Ambulatory Trial

Validation of the OIME index as a biomarker of pain in IBS participants, including the use of an abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain.

4 weeks

Weekly online logs

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final lab visit to measure primary outcomes and compare to baseline data.

4 weeks

Final lab visit

What Are the Treatments Tested in This Trial?

Interventions

• IBS-PPSM intervention

Trial Overview The study aims to record biosignals from IBS patients and healthy controls during pain episodes and validate an index called OIME as a biomarker for quantifying visceral pain in IBS patients.

How Is the Trial Designed?

Group I: IBS-PPSM intervention group Experimental Treatment 1 Intervention

After the baseline visit, the IBS-PPSM group will receive 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting. The IBS-PPSM group will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Group II: IBS-control group Active Control 1 Intervention

The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Citations

1. withpower.com withpower.com/trial/phase-visceral-pain-4-2025-531e5

IBS-PPSM for Irritable Bowel Syndrome (OIME Trial) Participants are monitored for safety and effectiveness after treatment, with a final lab visit to measure primary outcomes and compare to baseline data. 4 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3468694/

The Irritable Bowel Syndrome Outcome Study (IBSOS) After treatment, 62% of participants receiving MC-CBT described IBS symptoms as much or very much improved compared to 58% of patients receiving S-CBT and 7% on ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40258374/

Efficacy of dietary interventions in irritable bowel syndrome In terms of dietary interventions for IBS, the most evidence exists for a low FODMAP diet, but other promising therapies are emerging and should be the subject ...

4. mdpi.com mdpi.com/2077-0383/13/22/6948

A Review of Pharmacologic and Non ... Tegaserod has demonstrated significant improvement in the global relief of IBS-C symptoms, with 52% of patients reporting symptom reduction, though it did not ...

5. tgh.amegroups.org tgh.amegroups.org/article/view/8638/html

Management of irritable bowel syndrome: a narrative review A recent study assessing long-term efficacy and safety of tenapanor showed reduction in abdominal pain and global symptoms of IBS over 26 weeks (14). Similar to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7656202/

Efficacy and safety of non-pharmacological interventions for ... This study confirmed the efficacy and safety of NPIs for improving IBS symptoms, which to some extent recommended several interventions for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5794643/

Effects of Self-Management Interventions in Patients with ... Self-management group: decreased IBS-SSS, p<0.002; 23 (76.7%) of subjects in the self-management group experienced symptom relief. At 8 months 83% subjects in ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04133519

Efficacy and Safety of IBS Digital Behavioral Treatment EASITx is a pivotal study comparing two self-administered behavioral treatments for irritable bowel syndrome (IBS). The active treatment in EASITx is classified ...

9. ajmc.com ajmc.com/view/evidencebased-management-of-irritable-bowel-syndrome-with-diarrhea

Evidence-Based Management of Irritable Bowel Syndrome ... The efficacy and safety of pharmacologic agents for IBS, including data for harm events, where available, are discussed in detail in the next sections. Both ...