Evaluation of Gut-Related Well-Being and Mood Effects of a Daily Nutritional Food Ingredient From the Co-Fermentation of Fungal Mycelium (Pleurotus Pulmonarius) and Microalgae (Chlorella Vulgaris)

NCT07407777 · tracked via the Priya Life Science USA tracker

Sponsor

Koralo GmbH

Phase

Not applicable

Started

2026-01-19

Last updated

2026-02-12

Condition(s) studied

Gastrointestinal DiscomfortDigestive Well BeingGut-related Symptoms

Investigational drug(s) / intervention(s)

Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)

Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris): Food ingredient obtained from the co-fermentation of oyster mushroom mycelium (Pleurotus pulmonarius), microalgae (Chlorella vulgaris) and added bamboo fibre with flavours for better palatability

Study summary

The purpose of the study is to evaluate the gut-related well-being and mood effects of a food ingredient obtained from the co-fermentation of oyster mushroom mycelium (Pleurotus pulmonarius), microalgae (Chlorella vulgaris), and bamboo fibre in healthy adults (aged 18+) experiencing minor gastrointestinal discomfort during an intervention period of 30 days. The participants will be allocated into two unbalanced groups to determine relationships between the measurable outcomes and the dose levels at three different time points: start of the study (baseline), 15 days (middle), and 30 days (end-point), during which participants will be asked to complete GSRS and POMS-2-SF questionnaire

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: Adults aged 18 years or older Generally healthy individuals Experience minor, non-clinical gastrointestinal discomfort at least twice per week for ≥3 months Willing to consume the study product once daily for 30 days Able to dissolve and consume the powdered product in a beverage Able to read, understand, and complete electronic questionnaires in English Access to a smartphone or computer for study participation Provide electronic informed consent Exclusion Criteria: * Diagnosed gastrointestinal disease (e.g., IBS, IBD, GERD requiring medication) Use of medications affecting gastrointestinal function or mood within the past 30 days Initiation of new gut-, immune-, or mood-related supplements within 15 days prior to study start Known allergy or sensitivity to study product components Pregnancy or breastfeeding Major chronic medical condition that could interfere with study participation or data interpretation Participation in another interventional clinical study within the past 30 days Inability or unwillingness to comply with study procedures

Primary outcome measure(s)

Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score — Baseline (Day 0) to Day 30
The primary outcome is the change in gastrointestinal symptom severity as measured by the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated self-report questionnaire assessing the severity of common gastrointestinal symptoms. Change in total GSRS score will be evaluated over the course of the 30-day intervention to assess the effect of the investigational food ingredient on gut-related well-being.

Trial sites (1)

Facility	City	Region	Status
Alethios, Inc.	San Francisco	California	Recruiting

Other trials for the same condition

Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07407777 on ClinicalTrials.gov ↗ ← All trials in the USA