MHNA-001 for Young Adults With IBS

NCT05333926 | Completed FDA Device

• 1 other identifier: MHNA-001-003
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ IBS together with care as usual in approximately 100 young adults with Irritable Bowel Syndrome.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in IBS Severity Scoring System from Baseline to Week 12

  The IBS Severity Scoring System (IBS-SSS) is a validated, 5-item tool for measuring the severity of IBS symptoms in adults with IBS. The survey asks respondents to rate the severity and frequency of their abdominal pain, severity of abdominal distension, stool frequency and consistency, satisfaction with their bowel habits, and interference of IBS with life in general in the last 10 days using a 100-point visual analogue scale. Scores range from 0 to 500 with higher scores indicating more severe IBS symptoms. Mean score changes of 50 points or more over a 3-month period are predictive of a clinically significant improvement

  12 Weeks

Secondary Outcomes (1)

• Subject's Global Assessment of Relief at Week 12

  12 Weeks

Study Arms (1)

MHNA-001

EXPERIMENTAL

Device: MHNA-001

Interventions

MHNA-001 DEVICE

3-month digital therapy program designed to reduce the severity of IBS symptoms

Also known as: Mahana™ for IBS

MHNA-001

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant meets IBS diagnostic criteria via Rome IV questionnaire.
• Participant has IBS, based on IBS-SSS score of ≥125 at time of screening (corresponding to mild, moderate, or severe IBS).
• Participant is 18-21 years of age at the time of consent.
• Participant is able to speak, read, and understand English.
• Participant is capable and willing to complete questionnaires, track symptoms, and complete exercises associated with use of Mahana™ IBS.
• Participant has unrestricted access to an iOS (running iOS 13 or later) or Android smartphone with internet connectivity and sufficient space for Mahana™ IBS to be installed.
• If participant is taking any prescription IBS-related concomitant medications, he/she must have been on a stable dose/regimen for at least 30 days prior to the date of Screening/Enrollment and is not intended to make changes to dose or regimen during the treatment period (i.e., through Week 12 of the study).

You may not qualify if:

• Participant has a medical or psychiatric comorbidity that might account for GI symptoms, confound the measurement of IBS symptoms, or compromise the participant's ability to complete the study (ex. inflammatory bowel disease, chronic liver disease, substance abuse disorder, etc.) in the opinion of the investigator.
• Participant is currently using opioids or plans to use for chronic pain management and/or recreation.
• Participant has been hospitalized for psychiatric reasons within 12 months prior to screening.
• Participant is currently experiencing high depression symptom severity as indicated by a score \>14 on the PHQ-8.
• Participant is currently experiencing suicidal ideation as indicated by a score of 2 or 3 on item 9 of the Beck Depression Index (BDI). \*
• Participant is currently using any prescription digital therapeutic that delivers components of cognitive-behavioral therapies.
• Participant has undergone CBT, any other skills-based, or GI-specific psychological therapy (e.g. Dialectical Behavioral Therapy, Acceptance and Commitment Therapy, Behavioral Activation, Problem-solving Therapy, Gut-Directed Hypnotherapy, etc.) within 2 years of study entry.
• Participant has participated in any investigational trial within 30 days prior to Screening or plans to participate in another clinical trial during the study period.
• Participant is currently pregnant or nursing.

Sponsors & Collaborators

• Mahana Therapeutics: lead

Study Sites (1)

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: April 1, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

US (1)