Evaluation of the Effectiveness and Safety of Mool Healths customized Gut Health Regimen in Irritable Bowel Syndrome - A Double-Blind Study

This is a prospective, double-blind, clinical study designed to evaluate the clinical effectiveness and safety of Mool Health’s customized Gut Health Regimen over an 84-day intervention period in participants with irritable bowel syndrome (IBS). The primary objective is to assess changes in IBS symptom severity from baseline using tools such as the PI adapted IBS Symptom Severity Scale (IBS-SSS) and the Bristol Stool Chart.

Eligible participants aged 18 to 65 years, with a confirmed diagnosis of IBS, will be screened for inclusion and exclusion criteria. After providing informed consent, participants will undergo a detailed symptom evaluation conducted by the Principal Investigator (PI) using the PI Symptom Evaluation Form, the Online Symptom Evaluation Form, the PI adapted IBS-SSS, and the Bristol Stool Chart to establish baseline symptom severity.

Participants meeting the eligibility criteria will be scheduled for a kit dispensing visit, which may occur on the same day as screening or within 48 hours. During this visit, each participant will receive Mool Health’s customized Gut Health Regimen based on the PI’s clinical evaluation, the participant’s online symptom profile, and an algorithm-based software tool designed by study sponsor to ensure consistent and accurate kit customization. The regimen will include one or more combinations of Ayurvedic, and nutraceutical products designed to alleviate IBS symptoms. Participants will also receive a diary to record medication compliance and symptom progression.

The study intervention will last 12 weeks, during which participants will be monitored for safety, compliance, and symptom progression. Study assessments will be conducted at five key time points: a baseline screening visit (prior to regimen initiation) and follow-up visits on Days 21, 42, 63, and 84. At each follow-up visit, PI/ designee will complete the PI adapted IBS-SSS and the Bristol Stool Chart to evaluate changes in symptom severity.

The double-blind design ensures that neither participants nor Investigators are aware of the specific regimen composition, minimizing bias in outcome assessments. The final visit on Day 84 will serve as the end-of-study assessment to evaluate the overall effectiveness of the intervention and document any adverse events. This study design ensures robust data collection to support the evaluation of the Gut Health Regimen’s clinical utility in managing IBS symptoms.