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Efficacy and Safety of IBS Digital Behavioral Treatment

December 20, 2019

Overview

This study investigates the EASITx treatment for irritable bowel syndrome (IBS). The treatment is a medical device software that features video and audio recordings through a mobile application. The participants will be divided into two groups, one receiving the real treatment and the other receiving sham treatment to see how beneficial the treatment is for IBS.

 

Study Information

In this study, participants will be divided into two groups. The first group will be given 7 video/audio recordings in a mobile device every other week for 12 weeks. The second group will receive identical treatment in terms of the scheduling and reminders but the treatment recordings will be sham treatment. The investigators are looking for 380 participants and the trial is scheduled to be completed by June 2020.

 

Inclusion Criteria

 

  • Male or female
  • Ages 18-70
  • Confirmation of the IBS and IBS subtype diagnosis by a study site physician using Rome IV diagnostic criteria
  • Possess an iOS or Android smartphone or iOS tablet (iPad) released in 2015 or later
  • Agreement to input information about their abdominal pain and bowel movements on a daily basis into Curebase software
  • Agreement to have their anonymized data stored in the cloud for up to 2 years after the conclusion of the study, and to have the data used for research purposes.
  • Agreement to maintain stable dosage of IBS medications during the course of treatment and not to add new IBS medication or stop current IBS medications unless directed to do so by the participants treating physician. Changes in treatment will be captured using a concomitant medication assessment.
  • Average “Worst Daily Pain Severity” of >3 on a 11-point numeric rating scale (NRS) over the full 28-day symptom tracking period
  • Consistent submission of Pain Severity scores via the Curebase app (data submitted on 80% or more of days in the symptom tracking window)

 

Exclusion Criteria

 

  • Evidence of current structural intestinal abnormalities that better explain the participant’s IBS symptoms (e.g., celiac disease, inflammatory bowel disease – Crohn’s Disease and ulcerative colitis, prior abdominal surgeries such as weight loss surgery or bowel resection)
  • Medication use, other illnesses or conditions that can explain their gastrointestinal symptoms e.g.,regular narcotic use or dependency, OTC stimulant laxative dependence (i.e, progressively larger doses of Senna or Bisacodyl containing compounds are needed to produce a bowel movement), history of radiation to the abdomen.
  • Diagnosed and/or treated for a malignancy within the past 5 years (other than localized basal or squamous cell carcinomas of the skin)
  • Current psychotherapy, hypnotherapy, or cognitive behavioral therapy (CBT) for IBS
  • Inability to commit to completing all treatment sessions
  • Have an unstable extraintestinal condition whose immediate or foreseeable treatment needs would realistically interfere with study demands, e.g., ability to participate in online treatment sessions or follow daily diary.
  • Active psychiatric disorder (e.g., post-traumatic stress disorder, depression associated with high risk of suicidal behavior, psychotic or delusional disorders, dissociative disorders, or gross cognitive impairment)
  • Subjects that report a current gastrointestinal infection or an infection within the 4 weeks prior to the evaluation that would otherwise obscure IBS symptoms. In cases of gastrointestinal infection baseline evaluation will be delayed a minimum of 4 weeks until after complete recovery.
  • Current or recent use of a gut-targeted antibiotic such as Neomycin or Rifaximin during the 12 weeks prior to baseline assessment. In the case of treatment with rifaximin or neomycin, eligibility will be suspended for 12 weeks from the initial date of use.

 

Location

Curebase

San Francisco, California, United States, 94122

Contact: Tom Swanson    917-924-5957 ibsstudy@curebase.com

 

Sponsors/Collaborators

metaMe Health

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