Health Condition 1: K928- Other specified diseases of the digestive system Health Condition 2: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nitto SELF Wearable wrist watch device and MicroHeal Stool tracking Device: A wrist worn watch(Nitto and reference wearable device) that
Sponsors
Shashank Mishra
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-65 years. 2. Confirmed clinical diagnosis of IBS (according to Rome IV criteria) or a documented history of irregular stool patterns. 3. Willingness and ability to use the MicroHeal toilet sensor and Nitto SELF wearable daily. 4. Access to a home Wi-Fi network. 5. Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are active and having uncontrolled IBD like crohns disease and ulcerative colitis 2. Use of medications known to significantly alter gut motility or autonomic function unless on a stable dose for more than three months prior to enrollment 3. Physical or cognitive impairement preventing the use of the study devices 4. Participation in a concurrent clinical trial involving investigational drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To investigate how fluctuations in physiological stress markers correlate with bowel behavior (stool form, defecation effort) in people living with irritable bowel syndrome (IBS). 2. To quantify the association between short term fluctuations in wearable derived autonomic stress markers (HRV, resting HR) and contemporaneous changes in stool form/frequency and DASS21 scores.Timepoint: DAY 0- Baseline visit, Device dispensing, Training, Clinical History, Demographic information, Consent | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To Validate the technical integration and data integrity with the technologies into a single invasive system 2. To develop and validate AI model that uses stress linked gut motility patterns to predict IBS 3. To access the system ability to provide objective data that may help clinicians to differentiate IBS from IBD 4. To evaluate user adherance and platform acceptability and the impact of life intervention on patient quality of life and symptom awareness 5. Access fessibility and user acceptability of continuous digital monitoring over 28 daysTimepoint: Day 1 to 27 Daily wearable watch and stool tracking device, stool/image logging, Meal logging, app-based reporting, weekly adherence alerts. | — |
Countries
India
Contacts
Public ContactShashank Mishra
Microheal Wellness Private Limited
Outcome results
None listed