Dietary Supplement With and Without a Probiotic

Healthy Adult Subjects Clinical Trial

Official title:

Dietary Study of a Complex Oligosaccharide With and Without a Probiotic in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433208
• Other study ID #: 20-CT-001
• Status: Completed
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: December 2, 2020

Study information

• Verified date: August 2022
• Source: Prolacta Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 18-75.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthy adults between the ages of 18-75 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

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Dietary Supplement:
• Complex oligosaccharide
Complex oligosaccharide concentrate
• Probiotic
Probiotic

Other:
• PPI
Over-the-counter proton pump inhibitor (PPI)

Locations

Country	Name	City	State
United States	WCCT Global	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Prolacta Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the changes in microbiome species abundance and diversity from baseline until end of study		30 days
Secondary	Concentration of blood parameters, such as cytokine levels	Blood samples will be collected for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.	30 days
Secondary	Percentage of participants requiring PPI for probiotic engraftment	Determination of the need for protection of the probiotic from stomach acid in order for engraftment of the organism into the gut microbiome to occur	30 days
Secondary	Number and severity (mild, moderate, or severe) of adverse events and relationship to the study product.	Adverse events will be summarized by severity and relationship to the study drug	30 days