NCT04619875CompletedNot Applicable
A Randomized, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy Subjects
Kaleido Biosciences2 sites in 1 country36 target enrollmentStarted: September 11, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Safety as assessed by incidence of adverse advents
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To be eligible for inclusion, the patient must fulfill all of the following criteria at screening:
- •Able and willing to provide informed consent
- •Willing to provide multiple stool samples
- •Be male or female, ≥18 and ≤65 years of age
- •Have a body mass index ≥20 and <40 kg/m2
- •No current renal, hepatic or metabolic disease, significant dyslipidemia, or infection.
- •Willing to adhere to dietary requirements as stated in the protocol.
- •Willing to continue his/her normal diet and exercise routine.
- •Willing to continue taking any current supplements and vitamins, (with the exception of prebiotic or probiotic supplements) that the subject is currently taking, for the duration of the study.
- •Negative urine drug screen
- •If subject is female, have a negative urine pregnancy test at Screening and be willing to engage in method of contraception until completion of the study
- •Patients will be excluded from the study if they meet any of the following criteria at screening:
- •Currently taking probiotic or prebiotic dietary supplements, or have taken them in the past 28 days (prior to Screening Visit), or unwilling to avoid probiotic or probiotic dietary supplements for the duration of the study
- •Currently taking, or have taken in the last 7 days, drugs or other compounds to modulate gastrointestinal motility
- •Recent history (within six weeks of Screening) of the following conditions requiring medical attention or treatment, including over-the-counter medications: constipation, diarrhea, and/or acute GI illness.
- •Systemic antibiotics taken within the previous three months (prior to Screening Visit).
- •History of or active inflammatory bowel disease
- •History of or active irritable bowel syndrome
- •History of or active autoimmune disease
- •History of or active GI malignancy
- •Established pre-diabetic status (eg, multiple fasting blood glucose measurements 100 to 125 mg/dL inclusive, or history of failed glucose tolerance tests) and as assessed by HbA1c test
- •Have used an investigational drug or device within 30 dyas of study or be concurrently enrolled in another investigational drug or device study within 30 days of the study (prior to the Screening Visit)
- •Subject is a current smoker
- •Subject has a history of drug and/or alcohol abuse
- •Contraindications, sensitivity, or known allergy to the use of the study product(s) or their components
- •Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study (prior to the Screening Visit)
- •Individuals who, in the opinion of the PI, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety as assessed by incidence of adverse advents
Time Frame: Day -8 to Day 35
Tolerability as assessed by change in Bristol Stool Scale (BSS)
Time Frame: Day -8 to Day 35
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)
Tolerability as assessed by Gastrointestinal Tolerability Questionnaire (GITQ) score
Time Frame: Day -8 to Day 35
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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