Gastrointestinal DiscomfortNCT07407777
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)
A study testing Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris) in people with Gastrointestinal Discomfort and Digestive Well Being, run by Koralo GmbH at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Discomfort, Digestive Well Being, Gut-related Symptoms
- What is being tested?
- Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2026to 19 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zoe Benham, B.S. contact
United States1 site, 1 recruiting
- Recruiting
Alethios, Inc.
San Francisco, California, 94109
Zoe Benham, B.S., 9562771765, zoe@alethios.com
Zeenia Framroze, M.A., zeenia@alethios.com
About this study
Official title: 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) in Healthy Adults Experiencing Minor Gastrointestinal Discomfort: A 30-Day, Two-Arm, Open-Label Study
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
Read the detailed description
This study is a 30-day, two-arm, open-label dietary intervention designed to evaluate the effects of a daily nutritional food ingredient on gastrointestinal well-being and mood in generally healthy adults experiencing minor, non-clinical gastrointestinal discomfort. The investigational product is a powdered food ingredient derived from the co-fermentation of fungal mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris), blended with bamboo fiber and flavoring components for palatability. The product is food-grade, manufactured under cGMP conditions, and supported by a self-declared GRAS safety dossier. The study will enroll a total of 80 adult participants (aged 18-65) in the United States using a fully remote, decentralized design conducted through the Alethios digital research platform.
Participants who meet eligibility criteria will be randomly assigned in an unbalanced allocation to one of two fixed-dose intervention groups: a high-dose arm receiving 4,000 mg/day of the active blend (n=50) or a low-dose arm receiving 600 mg/day (n=30). All participants will consume the assigned product once daily for 30 days by mixing the powder into a beverage of their choice. No placebo group is included, as the primary objective is to explore dose-related effects rather than to compare against no treatment. The study involves no invasive procedures, clinical visits, laboratory testing, or biological sample collection, and participants may continue their usual diet and daily activities throughout the study period.
Study outcomes will be assessed using validated, self-reported questionnaires administered electronically at three time points: baseline (Day 0), mid-intervention (Day 15), and end of study (Day 30). The primary outcome is change in gastrointestinal symptom severity, measured by the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes include changes in mood and psychological well-being, assessed using the Profile of Mood States-2 Short Form (POMS-2-SF), as well as changes in GSRS subscale scores. Exploratory analyses will compare effect sizes between the two dose levels to assess potential dose-response relationships. Participant burden is minimal, with an estimated total time commitment of approximately 90 minutes over the entire study.
The study is classified as minimal risk, with anticipated risks limited to mild and transient gastrointestinal symptoms or rare allergic reactions consistent with the introduction of new dietary ingredients. Safety monitoring is conducted through daily self-report check-ins and adverse event reporting within the digital platform, with automated alerts to study staff as needed. Participants may withdraw at any time without penalty. Collectively, the study is designed to generate preliminary human evidence on the safety, tolerability, and potential benefits of the investigational food ingredient for gastrointestinal comfort and overall well-being in a mildly symptomatic, otherwise healthy adult population, providing a strong scientific rationale for future research.
- Being tested
- Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)
- Keywords
- gut health, gastrointestinal symptoms, functional food ingredient, mood and well-being, dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)Dietary supplement
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 group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Participants assigned to this arm will consume 600 mg per day of the investigational food ingredient (active blend) derived from the co-fermentation of Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae. The powdered product will be taken once daily for 30 days by mixing it into a beverage of the participant's choice. Gastrointestinal symptoms and mood-related outcomes will be assessed at baseline, Day 15, and Day 30 using validated self-report questionnaires. Receives: Dietary Supplement: Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris) |
| High Dose | Experimental | Participants assigned to this arm will consume 4,000 mg per day of the investigational food ingredient (active blend) derived from the co-fermentation of Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae. The powdered product will be taken once daily for 30 days by mixing it into a beverage of the participant's choice. Gastrointestinal symptoms and mood-related outcomes will be assessed at baseline, Day 15, and Day 30 using validated self-report questionnaires. Receives: Dietary Supplement: Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
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.
Measured: Baseline (Day 0) to Day 30
Secondary outcomes (1)
Change in Profile of Mood States-2 Short Form (POMS-2-SF) Total Mood Disturbance Score
The secondary outcome is the change in mood and psychological well-being as measured by the Profile of Mood States-2 Short Form (POMS-2-SF). The POMS-2-SF is a validated self-report questionnaire assessing mood states across multiple domains. Change in total mood disturbance score will be evaluated to assess the effect of the investigational food ingredient on mood and overall well-being during the intervention period.
Measured: Baseline (Day 0) to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start19 Jan 2026
- Primary completion19 May 2026 (estimated)
- Study completion19 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two parallel intervention arms receiving different fixed daily doses of the investigational food ingredient (high-dose and low-dose) over a 30-day period. There is no placebo or crossover; outcomes are assessed longitudinally at baseline, Day 15, and Day 30
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koralo GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407777
- Sponsor's protocol ID
- KOR001
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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) in Healthy Adults Experiencing Minor Gastrointestinal Discomfort: A 30-Day, Two-Arm, Open-Label Study
- ClinicalTrials.gov ID
- NCT07407777
- Acronym / sponsor ID
- KOR001
- Keywords
- gut health, gastrointestinal symptoms, functional food ingredient, mood and well-being, dietary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Koralo GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 19 May 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a 30-day, two-arm, open-label dietary intervention designed to evaluate the effects of a daily nutritional food ingredient on gastrointestinal well-being and mood in generally healthy adults experiencing minor, non-clinical gastrointestinal discomfort. The investigational product is a powdered food ingredient derived from the co-fermentation of fungal mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris), blended with bamboo fiber and flavoring components for palatability. The product is food-grade, manufactured under cGMP conditions, and supported by a self-declared GRAS safety dossier. The study will enroll a total of 80 adult participants (aged 18-65) in the United States using a fully remote, decentralized design conducted through the Alethios digital research platform.
Participants who meet eligibility criteria will be randomly assigned in an unbalanced allocation to one of two fixed-dose intervention groups: a high-dose arm receiving 4,000 mg/day of the active blend (n=50) or a low-dose arm receiving 600 mg/day (n=30). All participants will consume the assigned product once daily for 30 days by mixing the powder into a beverage of their choice. No placebo group is included, as the primary objective is to explore dose-related effects rather than to compare against no treatment. The study involves no invasive procedures, clinical visits, laboratory testing, or biological sample collection, and participants may continue their usual diet and daily activities throughout the study period.
Study outcomes will be assessed using validated, self-reported questionnaires administered electronically at three time points: baseline (Day 0), mid-intervention (Day 15), and end of study (Day 30). The primary outcome is change in gastrointestinal symptom severity, measured by the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes include changes in mood and psychological well-being, assessed using the Profile of Mood States-2 Short Form (POMS-2-SF), as well as changes in GSRS subscale scores. Exploratory analyses will compare effect sizes between the two dose levels to assess potential dose-response relationships. Participant burden is minimal, with an estimated total time commitment of approximately 90 minutes over the entire study.
The study is classified as minimal risk, with anticipated risks limited to mild and transient gastrointestinal symptoms or rare allergic reactions consistent with the introduction of new dietary ingredients. Safety monitoring is conducted through daily self-report check-ins and adverse event reporting within the digital platform, with automated alerts to study staff as needed. Participants may withdraw at any time without penalty. Collectively, the study is designed to generate preliminary human evidence on the safety, tolerability, and potential benefits of the investigational food ingredient for gastrointestinal comfort and overall well-being in a mildly symptomatic, otherwise healthy adult population, providing a strong scientific rationale for future research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized into two parallel intervention arms receiving different fixed daily doses of the investigational food ingredient (high-dose and low-dose) over a 30-day period. There is no placebo or crossover; outcomes are assessed longitudinally at baseline, Day 15, and Day 30
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Dietary Supplement: Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)Participants assigned to this arm will consume 600 mg per day of the investigational food ingredient (active blend) derived from the co-fermentation of Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae. The powdered product will be taken once daily for 30 days by mixing it into a beverage of the participant's choice. Gastrointestinal symptoms and mood-related outcomes will be assessed at baseline, Day 15, and Day 30 using validated self-report questionnaires. |
| High Dose | Experimental | Dietary Supplement: Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)Participants assigned to this arm will consume 4,000 mg per day of the investigational food ingredient (active blend) derived from the co-fermentation of Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae. The powdered product will be taken once daily for 30 days by mixing it into a beverage of the participant's choice. Gastrointestinal symptoms and mood-related outcomes will be assessed at baseline, Day 15, and Day 30 using validated self-report questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | High Dose, Low Dose |
Primary outcome
Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
Time frame: 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.
1 secondary outcome
Change in Profile of Mood States-2 Short Form (POMS-2-SF) Total Mood Disturbance Score
Time frame: Baseline (Day 0) to Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zoe Benham, B.S. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris) in people with Gastrointestinal Discomfort and Digestive Well Being, run by Koralo GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guido Albanese, PhD (+49 163 9144333, guido@koralo-foods.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (time frame: Baseline (Day 0) to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.