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This exploratory, randomized, open label study aims to explore the safety, tolerability, pharmacokinetics, and effects of increasing intake amounts of two novel glycans on the gut microbiota of healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose | Other |
| |
| KB5 | Other |
| |
| SG1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB5 | Other | KB5, a novel glycan, is a Kaleido laboratory code for KB174 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by incidence of adverse advents | Day -8 to Day 35 | |
| Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score | The GITQ is an assessment of the frequency and severity of GI symptoms, eg., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions | Day -8 to Day 35 |
| Tolerability as assessed by change in Bristol Stool Scale (BSS) | The BSS is an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid) | Day -8 to Day 35 |
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To be eligible for inclusion, the patient must fulfill all of the following criteria at screening:
Patients will be excluded from the study if they meet any of the following criteria at screening:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wingertzahn, PhD | Kaleido Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| SG1 |
| Other |
SG1 is a novel glycan |
|
| Lactulose | Other | Lactulose is a synthetic dissacharide |
|
| D000073893 |
| Sugars |