Fungal Fiber for Gut Health (NCT06404749) | Clinical Trial Compass
TerminatedNot Applicable
Fungal Fiber for Gut Health
Stopped: The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.
Argentina8 participantsStarted 2024-05-03
Plain-language 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.
Who can participate
Age range38 Years – 48 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 18.5 ≤ 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
GastroIntestinal Quality of Life Index
Timeframe: From enrollment to the end of treatment at 6 weeks