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The sponsor company was dissolved, resulting in insufficient funding to continue production of the investigational dietary supplement.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB01 | Experimental | fungal fiber, 150 mg/day, oral capsules, 2 weeks |
|
| inulin | Active Comparator | inulin, 3 g/day, oral capsules, 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fungal fiber | Dietary Supplement | fungal fiber from mycelium |
| |
| inulin |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Tartaglione | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultorios Del Dr Jorge Eduardo Tartaglione | Buenos Aires | Buenos Aires F.D. | 1123 | Argentina |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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data analysts
| Dietary Supplement |
long chain, degree of polymerization DP>23 |
|
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 |
| 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 |
| From enrollment to the end of treatment at 6 weeks |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |