TerminatedNot Applicable

Fungal Fiber for Gut Health

Stopped: The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.

Argentina8 participantsStarted 2024-05-03

Plain-language 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.

Who can participate

Age range

38 Years – 48 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GastroIntestinal Quality of Life Index

Timeframe: From enrollment to the end of treatment at 6 weeks

Trial details

NCT IDNCT06404749

SponsorFuture Biome SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-10

View on ClinicalTrials.gov More Mild Gastrointestinal Symptoms in Healthy Adults trials

Who can participate

Age range

38 Years – 48 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Volunteers permanently living in the Buenos Aires Metropolitan Area for at least 6 months prior to the intervention.

Fungal Fiber for Gut Health

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Fungal Fiber for Gut Health

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria