Dietary Supplement With and Without a Probiotic

Prolacta Bioscience

Status: Completed

Conditions: Healthy Adult Subjects

Treatments: Dietary Supplement: Complex oligosaccharide; Other: H2 Blocker; Dietary Supplement: Probiotic; Other: PPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT04433208

20-CT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 6 patient groups

Cohort 1 (Probiotic)

Experimental group

Description:

Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily

Treatment:

Dietary Supplement: Probiotic

Cohort 2 (Complex oligosaccharide)

Experimental group

Description:

Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily

Treatment:

Dietary Supplement: Complex oligosaccharide

Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic)

Experimental group

Description:

Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Complex oligosaccharide

Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic)

Experimental group

Description:

Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Complex oligosaccharide

Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker)

Experimental group

Description:

First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily \*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course

Treatment:

Other: PPI

Dietary Supplement: Probiotic

Other: H2 Blocker

Dietary Supplement: Complex oligosaccharide

Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic)

Experimental group

Description:

Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Complex oligosaccharide