| CTRI Number |
CTRI/2025/11/097865 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Prospective Observational Cohort Study on Integration of Wearable Derived Stress and sleep metrics through stool characteristics via MH Sense device to characterize Psychosomatic Health Profiling |
|
Scientific Title of Study
|
Integration of Wearable Derived Stress and Sleep Metrics and Stool Characteristics to Characterize Psychosomatic Health A Prospective Observational Cohort |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHW/2025-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavan Reddy Thondapu |
| Designation |
MBBS, MD, DM (Gastro) |
| Affiliation |
Arete Hospitals |
| Address |
Gastroenterology
Arete Hospitals
Hyderabad
Madhura Nagar Colony Gachibowli Telangana, 500081
Hyderabad
TELANGANA
500072
India |
| Phone |
7022252220 |
| Fax |
|
| Email |
pavanreddy.1857@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varun Aggarwala |
| Designation |
Assistant Professor & Researcher |
| Affiliation |
Microheal Wellness Private Limited |
| Address |
Jio Institute
Navi Mumbai
Science City
Ahmedabad
Pin 380060
Mumbai
MAHARASHTRA
410206
India |
| Phone |
9625666850 |
| Fax |
|
| Email |
varun.aggarwala@jioinstitute.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shashank Mishra |
| Designation |
CEO |
| Affiliation |
Microheal Wellness Private Limited |
| Address |
House 18
Silver spring bungalows 21 living
Divine road
Science City
Ahmedabad
House 18
Silver spring bungalows 21 living
Divine road
Science City
Ahmedabad
Pin: 380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
7376113646 |
| Fax |
|
| Email |
shashank@microheal.in |
|
|
Source of Monetary or Material Support
|
| MicroHeal Wellness Pvt. Ltd SILVER SPRING BUNGLOWS 21 LIVING BUNGALOW NO 18 DIVINE ROAD SCIENCE CITY AHMEDABAD 380060 |
|
|
Primary Sponsor
|
| Name |
Shashank Mishra |
| Address |
MicroHeal Wellness Private Limited
House-18
Silver spring bungalows 21 living, Divine road
Science City
Ahmedabad
Pin: 380060
House-18
Silver spring bungalows 21 living, Divine road
Science City
Ahmedabad
Pin: 380060 |
| Type of Sponsor |
Other [Healthcare] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavan Reddy Thondapu |
Arete Hospitals |
Gastroenterology Department Madhura Nagar Colony Gachibowli
Hyderabad
Hyderabad
TELANGANA |
7022252220
Pavanreddy.1857@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S2J Independant Ethics Committee Holistic Care and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nitto SELF Wearable wrist watch device and MicroHeal Stool tracking Device |
A wrist worn watch(Nitto and reference wearable device) that continuously streams real time heart rate heart rate variability and pulse pressure data via a secure encrypted API.
MicroHeal Stool Tracking Device A toilet-mounted device that captures
(a) Stool Images For AI-driven classification according to the Bristol Stool Chart (Types 1-7). (b) Audio Data Records grunting flush and effort sounds to assess bowel strain and confirm event integrity.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
DAY 0- Baseline visit, Device dispensing, Training, Clinical History, Demographic information, Consent
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 days |
Day 1 to 27 Daily wearable watch and stool tracking device, stool/image logging, Meal logging, app-based reporting, weekly adherence alerts. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, single-arm, observational cohort study aiming to objectively characterize the complex relationship between physiological stress, sleep, and gut function in adults with Irritable Bowel Syndrome (IBS) or irregular stool patterns. Problem: Functional gut disorders like IBS affect over 700 million people, and current diagnosis and management often rely on subjective patient-reported outcomes. The gut-brain-microbiome axis is central to these psychosomatic disorders. Need: Objective, non-invasive, continuous monitoring tools are needed to understand the temporal link between physiological states (stress/sleep) and gut function. Solution: Integrate consumer-grade wearable data (Heart Rate Variability - HRV, sleep) with AI-powered toilet sensor data (stool form, defecation effort) and serial stool microbiome analysis. Goal: Generate clinical evidence for stress-linked motility patterns, predict IBS flare-ups, and help differentiate IBS from Inflammatory Bowel Disease (IBD).
Study Design and MethodologyParticipants: 50 adults (40 with Rome IV-confirmed IBS, 10 without IBS) aged 18-65, recruited from gastroenterology clinics and digital campaigns in India. Exclusions: Active, uncontrolled IBD or use of medications significantly altering gut motility/autonomic function (unless stable for >3 months). Duration: 4 weeks (28 days) of continuous monitoring. Technology Nitto SELF Wearable: Wrist-worn device for streaming HR, HRV, and sleep metrics. MicroHeal Stool Tracking Device: Toilet-mounted device for capturing stool data and defecation effort. Custom Mobile App: For daily logging of the Bristol Stool Form Scale (BSFS) and self-reported mental health scales (DASS-21, PHQ-9, GAD-7).
|