Efficacy and Safety of IBS Digital Behavioral Treatment

NCT04133519 | Completed Results FDA Device

• 1 other identifier: MM001
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).

Conditions

Irritable Bowel Syndrome

Keywords

IBS - Irritable Bowel Syndrome; IBS; Irritable Bowel

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain Intensity Responder

  The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". An Abdominal Pain Intensity Responder is defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks post-treatment (weeks 13 through 16) is at least 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks pre-treatment (weeks -4 through -1).

  Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)

Secondary Outcomes (7)

• Abdominal Pain Intensity

  Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)

• Abdominal Pain Frequency

  Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16)

• Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale)

  Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)

• Daily Stool Frequency

  Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16)

• Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument

  Baseline (Week -4) to 4-weeks post-treatment (Week 16)

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD).

Device: Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)

Arm 2

ACTIVE COMPARATOR

Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)

Device: Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)

Interventions

Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) DEVICE

The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment.

Arm 1

Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) DEVICE

The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks.

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-70
• Confirmation of the IBS and IBS subtype diagnosis by a study site physician using Rome IV diagnostic criteria
• Possess an iPhone Operating System (iOS) Apple 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 pre-treatment 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)

You may not qualify if:

• 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, Over The Counter (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.
• Any condition that an investigator feels may interfere with the conduct of the study

Sponsors & Collaborators

• metaMe Health: lead

Study Sites (1)

Curebase

San Francisco, California, 94122, United States

Location

Related Publications (27)

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  BACKGROUND

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• Berry SK, Berry R, Recker D, Botbyl J, Pun L, Chey WD. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28.

  PMID: 37391055 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Neuromuscular Blockade

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Investigative Techniques

Results Point of Contact

• Title: Dr. David Recker, Chief Medical Officer
• Organization: metaMe Health

info@metamehealth.com

1-888-463-8262

Study Officials

• Lucy Pun, DO

  Elevated Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 21, 2019
• Study Start: October 23, 2019
• Primary Completion: October 28, 2020
• Study Completion: October 26, 2021
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)