Clinical trial NCT04433208: Dietary Supplement With and Without a Probiotic
Official title: Dietary Study of a Complex Oligosaccharide With and Without a Probiotic in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adult Subjects
Lead sponsor: Prolacta Bioscience
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.

Detailed description: The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health.

The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 18-44 years
* Willingness to complete all study procedures and clinic visits, and provide required samples
* Provides informed consent

Exclusion Criteria:

* Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
* Subjects with history of lactose intolerance
* Subjects who are on a PPI regimen
* Subjects who have taken a probiotic during the previous 30 days, or intends to take a probiotic during the study.
* Subjects who have taken antibiotics within 120 days
* Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening
* Unstable medical condition, in the opinion of the investigator
* Clinically significant abnormal laboratory test results at screening
* Participation in a clinical research trial within 30 days prior to screening
* Unable to give informed consent
* Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject

Primary outcomes:
measure: Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
timeFrame: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57
Secondary outcomes:
measure: Changes in Concentration of Blood Parameters From Day 1 to Day 15
timeFrame: Day 1 - 15
measure: Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
timeFrame: Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57
measure: Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
timeFrame: Day 1, 8, 15, 29
measure: Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)
timeFrame: Day 1 - 15
measure: Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)
timeFrame: Day 1 - 15
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
Study officials:
References: