Fungal Fiber for Gut Health

NCT ID: NCT06404749

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2024-12-24

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

FB01

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

Group Type: EXPERIMENTAL

fungal fiber

Intervention Type: DIETARY_SUPPLEMENT

fungal fiber from mycelium

inulin

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

Group Type: ACTIVE_COMPARATOR

inulin

Intervention Type: DIETARY_SUPPLEMENT

long chain, degree of polymerization DP\>23

Interventions

fungal fiber

fungal fiber from mycelium

Intervention Type: DIETARY_SUPPLEMENT

inulin

long chain, degree of polymerization DP\>23

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Future Biome SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Tartaglione

Role: PRINCIPAL_INVESTIGATOR

Locations

Consultorios Del Dr Jorge Eduardo Tartaglione

Buenos Aires, Buenos Aires F.D., Argentina

Countries

Argentina

Other Identifiers

FUN4GUT01

Identifier Type: -

Identifier Source: org_study_id