Digital Therapeutics for IBS

Science shows that your brain and gut are in nonstop contact. The link is so strong that scientists call your gut the "second brain." With irritable bowel syndrome (IBS), there is a breakdown in communication between the brain and gut. This causes your brain to misread and amplify normal signals. The result is stomach pain, diarrhea, and constipation.^1,2

Digital therapeutics are a treatment that use virtual therapy to balance the brain-gut connection and relieve IBS symptoms. Programs last for multiple months and use different therapy techniques.

Examples of digital therapeutics for IBS

The US Food and Drug Administration (FDA) has approved 2 digital therapeutics for IBS:^1-3

Regulora® is the first FDA-approved treatment for IBS abdominal pain in adults. The mobile app offers seven 30-minute sessions of virtual therapy over 3 months. The video sessions are based on a type of therapy called Gut-Directed Hypnotherapy (GDH). Until now, doctors could only offer GDH in a medical clinic.

Parallel^TM (now called Mahana IBS) is a digital program for adults with IBS. The 3-month program uses cognitive-behavioral therapy (CBT) to help ease IBS symptoms. Those who use the program get customized feedback through symptom, mental, and physical health tracking. Users also develop new IBS management skills and habits.

Researchers have studied Parallel and Regulora in clinical trials to determine how well they work.

More than 350 people took part in a clinical trial to evaluate Regulora. Results showed 68 percent of people who used the app were satisfied with the treatment. And, 87 percent would suggest Regulora to another person with IBS.²

Researchers have published 2 studies on Parallel. They compared Parallel, phone-based CBT, and face-to-face sessions without CBT. People living with ongoing IBS took part in the studies.^4,5

Researchers measured both physical symptoms and the impact on participants' work and social lives. Study results show phone-based and digital CBT improved symptoms more often than standard therapy. Researchers found 63 percent of people enrolled in the digital CBT program had fewer IBS symptoms. They followed up with study participants over 2 years.^4,5

Digital therapeutics side effects

There are no serious side effects of digital therapy for IBS. Around 1 percent of people who used the Regulora app in a clinical trial showed mild symptoms. They include stomach pain, constipation, fatigue, and headache.²

Important information about digital therapeutics

There are other app-based therapies that may help with IBS symptoms, but they are not approved by the FDA. Regulora and Parallel are only available by prescription to adults with IBS who are at least 22 years old.^1,2

To use Parallel, you must be able to read and understand English. You will also need a web-enabled desktop or laptop computer and know how to use web applications. People using Regulora must have an Apple or Android smartphone.^1,2

Developers of these digital IBS programs say they should not replace standard therapy with a mental health professional. But they can supplement traditional therapy, including for people without access to this service.

Additional IBS therapies

Digital therapeutics are just 1 of many therapies for IBS. Other treatments include:⁶

• Lifestyle changes – Avoiding trigger foods, regular exercise, controlling stress, and drinking lots of fluid
• Over-the-counter medicines – Fiber supplements, laxatives, and medicines to control diarrhea
• Prescription medicines – Depression medicine, pain medicine, and IBS-targeted medicines
• Alternative treatments – Hypnosis, peppermint tablets, and probiotics

Your doctor will help you choose the best treatment to ease your symptoms.