Clinical trial NCT06404749: Fungal Fiber for Gut Health
Official title: Fungal Fiber for Gut Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: gut microbiome
gut health
healthy women
perimenopause
pre menopause
middle aged women
fiber
gut brain axis
low grade chronic inflammation
prebiotic
Lead sponsor: Future Biome SA
Sponsor class: INDUSTRY
First posted: 2024-05-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: GastroIntestinal Quality of Life Index
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Bristol
timeFrame: From the enrollment to the end of treatment at 6 weeks
measure: Wisconsin Upper Respiratory Symptom Survey
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Positive and Negative Affect Schedule
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Work Productivity and Activity Impairment
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: basal cortisol
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: hs-CRP
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: calprotectin
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Short Chain Fatty Acids
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
measure: microbiome metagenomics
timeFrame: from enrollment to the end of treatment at 6 weeks
measure: microbiome metatranscriptomics
timeFrame: From enrollment to the end of treatment at 6 weeks
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorios Del Dr Jorge Eduardo Tartaglione
state: Caba
Study officials:
name: Javier Tartaglione
role: PRINCIPAL_INVESTIGATOR
References: