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Fungal fiber gut health trial ends early – little to go on

NCT ID NCT06404749

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to compare a fiber from fungi (mycelium) with a plant-based fiber (inulin) for effects on gut health, immunity, and stress in healthy women aged 37-48. Only 8 participants were enrolled before the trial was terminated, so the results are too limited to draw meaningful conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fungal fiber from mycelium
What this could lead to
If successful, this could suggest that fungal fiber is a better option than plant fiber for improving gut health and reducing stress.
What could go wrong
The trial was terminated early with only 8 participants, so results are very limited and may not be reliable or generalizable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

8 people

The number who actually took part.

Started

May 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

38 to 48 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of a signed and dated informed consent form 2. Declared willingness to comply with all study procedures and availability during the study. 3. Female, \>37 years, ≤48 years 4. 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 5. Fiber intake \<20g/day according to R24 6. 18.5 ≤ BMI ≤ 29.9 7. Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention. 8. Ability to take oral capsules and willingness to comply with intervention regimen of the study. 9. Agreement to comply with lifestyle considerations during the study. Exclusion Criteria: 1. History of chronic immune, metabolic or gastrointestinal diseases. 2. History of gastrointestinal surgery. 3. Acute illness within one week prior to screening. 4. Treatment with oral or systemic antibiotics within 3 months prior to screening. 5. Hospitalization within 3 months prior to screening. 6. Consumption of laxatives or antidiarrheals, antispasmodic agents, antacids, anti-inflammatories within three days prior to screening. 7. Current intake of fiber or prebiotics as a supplement, or probiotics as a supplement. 8. Vegan, vegetarian or on a special diet. 9. Pregnancy or breastfeeding. 10. Menopause (absence of menstruation for 12 consecutive months) or postmenopause. 11. Known allergic reactions to components of the study interventions: inulin, beta-glucan, mushrooms, magnesium stearate, microcrystalline cellulose, hydroxypropylmethylcellulose. 12. Treatment with another investigational drug or other intervention in the last 6 months. 13. Receives pharmacological intervention for the treatment of a disease 14. Any disorder that, in the opinion of the investigator, could jeopardize safety of the participant.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Consultorios Del Dr Jorge Eduardo Tartaglione

    Buenos Aires, Buenos Aires F.D., 1123, Argentina

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