Fungal Fiber for Gut Health (FUN4GUT)

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.

Study Overview

• Status: Terminated
• Conditions: Immune Response; Stress; Nutrition, Healthy; Gut Microbiome; Low-grade Chronic Inflammation; Activity of Daily Living; Gut Health; Mild Gastrointestinal Symptoms in Healthy Adults; Gut Permeability
• Intervention / Treatment: Dietary supplement: fungal fiber; Dietary supplement: inulin

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1123
      • Consultorios Del Dr Jorge Eduardo Tartaglione

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FB01; fungal fiber, 150 mg/day, oral capsules, 2 weeks	Dietary supplement: fungal fiber; fungal fiber from mycelium
Active Comparator: inulin; inulin, 3 g/day, oral capsules, 2 weeks	Dietary supplement: inulin; long chain, degree of polymerization DP>23

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
basal cortisol	basal cortisol	From enrollment to the end of treatment at 6 weeks
hs-CRP	high sensitivity C Reactive Protein	From enrollment to the end of treatment at 6 weeks
calprotectin	fecal	From enrollment to the end of treatment at 6 weeks
Short Chain Fatty Acids	fecal and serum SCFA	From enrollment to the end of treatment at 6 weeks
Bristol	Bristol scale and frequency chart. Frequency and consistence of feces, self assessed questionnaire. Range 1 to 7. Optimal value: 4. Values 1-3: different levels of constipation. Values 6-7: different levels of diarrhea	From the enrollment to the end of treatment at 6 weeks
Wisconsin Upper Respiratory Symptom Survey	Wisconsin Upper Respiratory Symptom Survey (WURSS41) scale, self assessed questionnaire, range 0 (desired) to 301 (undesired)	From enrollment to the end of treatment at 6 weeks
Positive and Negative Affect Schedule	PANAS, self assessed questionnaire. Range from 10 (lowest) to 50 (highest) for both positive and negative scale	From enrollment to the end of treatment at 6 weeks
Work Productivity and Activity Impairment	WPAI, self assessed questionnaire, range 0 (desired) to 100 (undesired)	From enrollment to the end of treatment at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiome metagenomics	gut microbiome taxonomy: abundance, diversity	from enrollment to the end of treatment at 6 weeks
microbiome metatranscriptomics	expression of gut microbial genes	From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: Future Biome SA
• Investigators: Principal Investigator: Javier Tartaglione

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 24, 2024

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: prebiotic; gut microbiome; gut brain axis; perimenopause; fiber; gut health; healthy women; low grade chronic inflammation; pre menopause; middle aged women
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Dietary Carbohydrates; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Starch; Glucans; Biopolymers; Fructans; Inulin
• Other Study ID Numbers: FUN4GUT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: a decision has not been made yet
• IPD Sharing Time Frame: a decision has not been made yet
• IPD Sharing Access Criteria: a decision has not been made yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No