Fungal Fiber for Gut Health

Stress Clinical Trial

— FUN4GUT  

Official title:

Fungal Fiber for Gut Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404749
• Other study ID #: FUN4GUT01
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2024
• Est. completion date: May 3, 2026

Study information

• Verified date: May 2024
• Source: Future Biome SA
• Contact: Javier Tartaglione
• Phone: 541148134563
• Email: Javier[@]tartaglione.com.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 3, 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 38 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• fungal fiber
fungal fiber from mycelium
• inulin
long chain, degree of polymerization DP>23

Locations

Country	Name	City	State
Argentina	Consultorios Del Dr Jorge Eduardo Tartaglione	Ciudad Autonoma de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Future Biome SA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	microbiome metagenomics	gut microbiome taxonomy: abundance, diversity	from enrollment to the end of treatment at 6 weeks
Other	microbiome metatranscriptomics	expression of gut microbial genes	From enrollment to the end of treatment at 6 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	basal cortisol	basal cortisol	From enrollment to the end of treatment at 6 weeks
Secondary	hs-CRP	high sensitivity C Reactive Protein	From enrollment to the end of treatment at 6 weeks
Secondary	calprotectin	fecal	From enrollment to the end of treatment at 6 weeks
Secondary	Short Chain Fatty Acids	fecal and serum SCFA	From enrollment to the end of treatment at 6 weeks