# Efficacy and Safety of IBS Digital Behavioral Treatment

> **NCT04133519** · NA · COMPLETED · sponsor: **metaMe Health** · enrollment: 378 (actual)

## Conditions studied

- Irritable Bowel Syndrome

## Interventions

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

## Key facts

- **NCT ID:** NCT04133519
- **Lead sponsor:** metaMe Health
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-10-23
- **Primary completion:** 2020-10-28
- **Final completion:** 2021-10-26
- **Target enrollment:** 378 (ACTUAL)
- **Last updated:** 2022-05-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04133519

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04133519, "Efficacy and Safety of IBS Digital Behavioral Treatment". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT04133519. Licensed CC0.

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