NCT04133519: EASITx

Efficacy and Safety of IBS Digital Behavioral Treatment

Completed NA Results posted Last updated 4 May 2022

What this trial tests

NA trial testing Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) in Irritable Bowel Syndrome in 378 participants. Completed in 26 October 2021.

Timeline

23 October 2019

Primary endpoint
28 October 2020

26 October 2021

Quick facts

Lead sponsor	metaMe Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	378
Start date	23 October 2019
Primary completion	28 October 2020
Estimated completion	26 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)
• Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

metaMe Health

Who can join

Adults 18 to 70, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Abdominal Pain Intensity Responder Primary · 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)

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).

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	55
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	49

Abdominal Pain Intensity Secondary · 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)

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". Mean change in reported abdominal pain intensity.

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	-0.995	± 1.66
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	-1.031	± 1.68

Abdominal Pain Frequency Secondary · Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16)

Mean change in reported abdominal pain frequency. The abdominal pain frequency is based on the frequency of abdominal pain measured using 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". Average abdominal pain frequency is defined as the average number of days per week during the 4-week post-treatment assessment period in which the subjects recorded a 1 or greater on the daily pain measurement. Only days during which an assessment is recorded will be included in the calculation of average a

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	-0.366	± 1.1272
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	-0.437	± 1.2437

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

Number of Participants with a ≥ 30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fell within Group 2 (normal stools) compared with baseline (Weeks -4 through -1). The result represents the number of participants with ≥ 30% improvement in the percentage of normal stools The BSFS is a visual aid that allows patients to classify their bowel movements into seven groups ranging from a score of 1 (separate hard lumps) to 7 (watery, no solid pieces). The BSFS scores will be grouped as 1,2 (Group 1), 3,4,5 (Group 2) and 6,7 (Group 3). The mid-range bowel movements 3,4 a

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	77
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	72

Daily Stool Frequency Secondary · 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)

Mean change in reported daily stool frequency Analyses of change in daily stool frequency will only include participants with IBS-C and IBS-D. IBS-C and IBS-D subtypes will be analyzed independently.

IBS-C subgroup of participants

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	-0.074	± 0.8964
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	0.151	± 0.4531

IBS-D subgroup of participants

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	-0.325	± 0.6915
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	-0.455	± 1.2904

Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument Secondary · Baseline (Week -4) to 4-weeks post-treatment (Week 16)

The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 items are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. IBS QOL scores will be compared pre- and post-treatment and the mean difference compared by treatment.

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	8.075	± 19.2567
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	5.816	± 23.0150

Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire Secondary · Baseline (Week -4) to 4-weeks post-treatment (Week 16)

Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productiv

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	-18.1	± 27.59
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	-14.4	± 25.22

Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire Secondary · 4-weeks post-treatment (Week 16)

Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productiv

Group	Value	95% CI
Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD	42.9	± 25.92
MR-1; Muscle Relaxation, Software as a Medical Device - SaMD	40.2	± 28.06

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD

Serious: 1/188 (1%)

Deaths: 0/188

MR-1; Muscle Relaxation, Software as a Medical Device - SaMD

Serious: 0/190 (0%)

Deaths: 0/190

Serious adverse events (4 terms)

Reaction	System	Regulora; Gut-Directed Hyp…	MR-1; Muscle Relaxation, S…
COVID-19	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Idiopathic intracranial hypertension	Nervous system disorders	—	—
Arnold-Chiari malformation	Nervous system disorders	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Regulora; Gut-Directed Hyp…	MR-1; Muscle Relaxation, S…
Abdominal pain	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Dydpepsia	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Neuropathy peripheral	Nervous system disorders	—	—
Somnolence	Nervous system disorders	—	—
Panic attack	Psychiatric disorders	—	—
Thrombosis	Vascular disorders	—	—

Most-reported serious reactions: COVID-19, Pneumonia, Idiopathic intracranial hypertension, Arnold-Chiari malformation.

Data from ClinicalTrials.gov NCT04133519 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.