Mild Gastrointestinal Symptoms in Healthy AdultsFUN4GUTNCT06404749
Fungal Fiber for Gut Health
A study testing fungal fiber and inulin in people with Mild Gastrointestinal Symptoms in Healthy Adults and Low-grade Chronic Inflammation, run by Future Biome SA at 1 site in Argentina.
Trial summary
This study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses. Read more about this study
- Who is it for?
- Ages 38 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Gastrointestinal Symptoms in Healthy Adults, Low-grade Chronic Inflammation, Stress
- What is being tested?
- fungal fiber and inulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteArgentina
- Study dates
- 3 May 2024to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 38 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of a signed and dated informed consent form
- Declared willingness to comply with all study procedures and availability during the study.
- Female, >37 years, ≤48 years
- Healthy volunteers who have experienced at least one of the following Gastrointestinal symptoms in the last week: abdominal pain, full stomach, bloating, accidental leakage of intestinal gas, loud belching, bowel movements more frequent than usual, discomfort when eating, with a GIQLI score <121
- Fiber intake <20g/day according to R24
- 18.5 ≤ BMI ≤ 29.9
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- Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention.
- Ability to take oral capsules and willingness to comply with intervention regimen of the study.
- Agreement to comply with lifestyle considerations during the study.
Who cannot join
- History of chronic immune, metabolic or gastrointestinal diseases.
- History of gastrointestinal surgery.
- Acute illness within one week prior to screening.
- Treatment with oral or systemic antibiotics within 3 months prior to screening.
- Hospitalization within 3 months prior to screening.
- Consumption of laxatives or antidiarrheals, antispasmodic agents, antacids, anti-inflammatories within three days prior to screening.
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- Current intake of fiber or prebiotics as a supplement, or probiotics as a supplement.
- Vegan, vegetarian or on a special diet.
- Pregnancy or breastfeeding.
- Menopause (absence of menstruation for 12 consecutive months) or postmenopause.
- Known allergic reactions to components of the study interventions: inulin, beta-glucan, mushrooms, magnesium stearate, microcrystalline cellulose, hydroxypropylmethylcellulose.
- Treatment with another investigational drug or other intervention in the last 6 months.
- Receives pharmacological intervention for the treatment of a disease
- Any disorder that, in the opinion of the investigator, could jeopardize safety of the participant.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Consultorios Del Dr Jorge Eduardo Tartaglione
Buenos Aires, Buenos Aires F.D., 1123
About this study
This study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses.
- Conditions
- Mild Gastrointestinal Symptoms in Healthy Adults, Low-grade Chronic Inflammation, Stress, Gut Health, Gut Permeability, Gut Microbiome
- Being tested
- fungal fiber, inulin
- Keywords
- gut microbiome, gut health, healthy women, perimenopause, pre menopause, middle aged women, fiber, gut brain axis, low grade chronic inflammation, prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fungal fiberDietary supplement
fungal fiber from mycelium
inulinDietary supplement
long chain, degree of polymerization DP>23
| Study group | Role | What they receive |
|---|---|---|
| FB01 | Experimental | fungal fiber, 150 mg/day, oral capsules, 2 weeks Receives: Dietary Supplement: fungal fiber |
| inulin | Active comparator | inulin, 3 g/day, oral capsules, 2 weeks Receives: Dietary Supplement: inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
GastroIntestinal Quality of Life Index
GastroIntestinal Quality of Life Index (GIQLI), self assessed questionnaire, minimum score 0 (low quality), maximum score 144 (high quality)
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (8)
Bristol
Bristol scale and frequency chart. Frequency and consistence of feces, self assessed questionnaire. Range 1 to 7. Optimal value: 4. Values 1-3: different levels of constipation. Values 6-7: different levels of diarrhea
Measured: From the enrollment to the end of treatment at 6 weeks
Wisconsin Upper Respiratory Symptom Survey
Wisconsin Upper Respiratory Symptom Survey (WURSS41) scale, self assessed questionnaire, range 0 (desired) to 301 (undesired)
Measured: From enrollment to the end of treatment at 6 weeks
Positive and Negative Affect Schedule
PANAS, self assessed questionnaire. Range from 10 (lowest) to 50 (highest) for both positive and negative scale
Measured: From enrollment to the end of treatment at 6 weeks
Work Productivity and Activity Impairment
WPAI, self assessed questionnaire, range 0 (desired) to 100 (undesired)
Measured: From enrollment to the end of treatment at 6 weeks
basal cortisol
basal cortisol
Measured: From enrollment to the end of treatment at 6 weeks
hs-CRP
high sensitivity C Reactive Protein
Measured: From enrollment to the end of treatment at 6 weeks
calprotectin
fecal
Measured: From enrollment to the end of treatment at 6 weeks
Short Chain Fatty Acids
fecal and serum SCFA
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start3 May 2024
- Primary completion10 Dec 2024
- Study completion24 Dec 2024
Why it stopped: The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Gastrointestinal Symptoms in Healthy AdultsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future Biome SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Tartaglione, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404749
- Sponsor's protocol ID
- FUN4GUT01
- Acronym
- FUN4GUT
- Status last verified
- Jan 2026
- First submitted
- 5 May 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: a decision has not been made yet
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungal Fiber for Gut Health
- ClinicalTrials.gov ID
- NCT06404749
- Acronym / sponsor ID
- FUN4GUT / FUN4GUT01
- Conditions
- Mild Gastrointestinal Symptoms in Healthy Adults, Low-grade Chronic Inflammation, Stress, Gut Health, Gut Permeability, Gut Microbiome
- Keywords
- gut microbiome, gut health, healthy women, perimenopause, pre menopause, middle aged women, fiber, gut brain axis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Future Biome SAIndustry (pharma, biotech, devices)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 8 May 2024 (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.
This study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FB01 | Experimental | Dietary Supplement: fungal fiberfungal fiber, 150 mg/day, oral capsules, 2 weeks |
| inulin | Active comparator | Dietary Supplement: inulininulin, 3 g/day, oral capsules, 2 weeks |
Who may qualify
- Ages
- 38 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of a signed and dated informed consent form
- Declared willingness to comply with all study procedures and availability during the study.
- Female, >37 years, ≤48 years
- Healthy volunteers who have experienced at least one of the following Gastrointestinal symptoms in the last week: abdominal pain, full stomach, bloating, accidental leakage of intestinal gas, loud belching, bowel movements more frequent than usual, discomfort when eating, with a GIQLI score <121
- Fiber intake <20g/day according to R24
Key exclusion criteria (14 listed)
- History of chronic immune, metabolic or gastrointestinal diseases.
- History of gastrointestinal surgery.
- Acute illness within one week prior to screening.
- Treatment with oral or systemic antibiotics within 3 months prior to screening.
- Hospitalization within 3 months prior to screening.
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 |
|---|---|---|
| fungal fiberfungal fiber from mycelium | Dietary supplement | FB01 |
| inulinlong chain, degree of polymerization DP>23 | Dietary supplement | inulin |
Primary outcome
GastroIntestinal Quality of Life Index
Time frame: From enrollment to the end of treatment at 6 weeks
GastroIntestinal Quality of Life Index (GIQLI), self assessed questionnaire, minimum score 0 (low quality), maximum score 144 (high quality)
8 secondary outcomes
Bristol
Time frame: From the enrollment to the end of treatment at 6 weeks
Wisconsin Upper Respiratory Symptom Survey
Time frame: From enrollment to the end of treatment at 6 weeks
Positive and Negative Affect Schedule
Time frame: From enrollment to the end of treatment at 6 weeks
Work Productivity and Activity Impairment
Time frame: From enrollment to the end of treatment at 6 weeks
basal cortisol
Time frame: From enrollment to the end of treatment at 6 weeks
hs-CRP
Time frame: From enrollment to the end of treatment at 6 weeks
calprotectin
Time frame: From enrollment to the end of treatment at 6 weeks
Short Chain Fatty Acids
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
The study was stopped early (reason given: The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. a decision has not been made yet
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. This study is not recruiting at the moment.
Javier Tartaglione principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fungal fiber and inulin in people with Mild Gastrointestinal Symptoms in Healthy Adults and Low-grade Chronic Inflammation, run by Future Biome SA at 1 site in Argentina.
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 9 inclusion and 14 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: stopped early, as of the sponsor's last update on 14 Jan 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 Argentina. 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?
The study was stopped early (reason given: The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GastroIntestinal Quality of Life Index (time frame: From enrollment to the end of treatment at 6 weeks). 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 14 Jan 2026.