Fungal Fiber for Gut Health

What this trial studies

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 in scope

• Mild Gastrointestinal Symptoms in Healthy Adults
• Low-grade Chronic Inflammation
• Stress
• Gut Health
• Gut Permeability
• Gut Microbiome
• Immune Response
• Activity of Daily Living

Interventions

• fungal fiber (Dietary Supplement) — fungal fiber from mycelium
• inulin (Dietary Supplement) — long chain, degree of polymerization DP\>23

Who can join

Women only · Ages 38 Years to 48 Years · Accepts healthy volunteers.

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
• ≤ BMI ≤ 29.9
• 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.

Exclusion criteria

• 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.
• Current intake of fiber or prebiotics as a supplement, or probiotics as a supplement.
• Vegan, vegetarian or on a special diet.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Terminated
• Study type: Interventional
• Phase: N/A
• Start date: 2024-05-03
• Primary completion: 2024-12-10
• Last update posted: 2026-01-14
• First posted: 2024-05-08

Sponsor & contact

Lead sponsor: Future Biome SA (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• GastroIntestinal Quality of Life Index (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)

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