Fungal Fiber for Gut Health

NCT06404749 | Terminated DMC

• 1 other identifier: FUN4GUT01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

gut microbiome; gut health; healthy women; perimenopause; pre menopause; middle aged women; fiber; gut brain axis; low grade chronic inflammation; prebiotic

Outcome Measures

Primary Outcomes (1)

• GastroIntestinal Quality of Life Index

  GastroIntestinal Quality of Life Index (GIQLI), self assessed questionnaire, minimum score 0 (low quality), maximum score 144 (high quality)

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (8)

• Bristol

  From the enrollment to the end of treatment at 6 weeks

• Wisconsin Upper Respiratory Symptom Survey

  From enrollment to the end of treatment at 6 weeks

• Positive and Negative Affect Schedule

  From enrollment to the end of treatment at 6 weeks

• Work Productivity and Activity Impairment

  From enrollment to the end of treatment at 6 weeks

• basal cortisol

  From enrollment to the end of treatment at 6 weeks

Other Outcomes (2)

• microbiome metagenomics

  from enrollment to the end of treatment at 6 weeks

• microbiome metatranscriptomics

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

FB01

EXPERIMENTAL

fungal fiber, 150 mg/day, oral capsules, 2 weeks

Dietary Supplement: fungal fiber

inulin

ACTIVE COMPARATOR

inulin, 3 g/day, oral capsules, 2 weeks

Dietary Supplement: inulin

Interventions

fungal fiber DIETARY_SUPPLEMENT

fungal fiber from mycelium

FB01

inulin DIETARY_SUPPLEMENT

long chain, degree of polymerization DP\>23

inulin

Eligibility Criteria

• Age: 38 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Agreement to comply with lifestyle considerations during the study.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Future Biome SA: lead

Study Sites (1)

Consultorios Del Dr Jorge Eduardo Tartaglione

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

Location

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Javier Tartaglione

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: data analysts
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 3, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 24, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: a decision has not been made yet
• Access Criteria: a decision has not been made yet

Locations

AR (1)