Dietary Supplement With and Without a Probiotic and/or Antibiotic

Completed

Interventions: Dietary Supplement: Dietary supplement, probiotic, antibiotic conditioning -all groups

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 who have received antibiotics. The combination should support general gastrointestinal health.

This study is a multi-dose randomized cohort trial using 18 subjects per cohort for a total of 90 healthy adult volunteers ages 18-75.

Recruitment & Eligibility

Inclusion Criteria

Healthy adults between the ages of 18-75 years (subjects must be 18-75 at the time of consent) who can provide proof of vaccination against SARS-CoV-2. Proof may be a physical or electronic record of vaccination or self-attestation (to include approximate vaccination date and manufacturer of vaccine) if a copy of the vaccination record is not available
Subjects must have a BMI of 18 - 30 at screening visit
Willingness to complete study specific questionnaires
Willingness to complete journal to record IP dosing times, Bristol stool scores, and IP flavor questionnaires
Willingness to complete all study procedures, clinic visits, and provide required biospecimen samples
Willingness to collect and process stool samples at home and transport stool samples to clinic
Sexually active females of child-bearing potential must agree to use highly effective methods of contraception during heterosexual intercourse throughout the study period and for three days following discontinuation of IP, whichever comes later. Examples of highly effective methods include the use of two forms of contraception with one being an effective barrier method (e.g., a condom and spermicide used together), or have a vasectomised partner. Abstinence is acceptable as a life-style choice. Female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing
Provide informed consent

Exclusion Criteria

Subjects with a BMI of 17 or less or 31 or greater are excluded
Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
Subjects who intend to take a probiotic during the study
Subjects with self-reported diarrhea on day 1 prior to dosing, whereby diarrhea is defined as two or more episodes of watery and/or unformed stool within 24 hours
Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening and day 1 of the study
Unstable medical condition, in the opinion of the investigator
Subject with a history of allergy to the study antibiotics
Clinically significant abnormal laboratory test results at screening
Subjects who are unable or unwilling to provide stool samples on a regular basis as per study protocol
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
Known carriers of C. difficile prior to study start, as determined by qPCR of stool
Known carriers of vancomycin-resistant enterococci (VRE) prior to study start, as determined by stool culture
Subjects with history of lactose intolerance

Arm && Interventions

Group	Intervention	Description
Arm 4	Dietary supplement, probiotic, antibiotic conditioning -all groups	Antibiotic conditioning, Dose ranging of dietary supplement with and probiotic.
Arm 1	Dietary supplement, probiotic, antibiotic conditioning -all groups	Antibiotic conditioning
Arm 5	Dietary supplement, probiotic, antibiotic conditioning -all groups	Antibiotic conditioning and probiotic treatment.
Arm 2	Dietary supplement, probiotic, antibiotic conditioning -all groups	Antibiotic conditioning, Dose ranging of dietary supplement with and probiotic.
Arm 3	Dietary supplement, probiotic, antibiotic conditioning -all groups	Antibiotic conditioning, Dose ranging of dietary supplement with and probiotic.

Primary Outcome Measures

Name	Time	Method
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)	Baseline, Day, 5, 14, 35	Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.

Secondary Outcome Measures

Name	Time	Method
Changes in Immune Markers Assessment at Day 5, 14 and 28	Baseline-28 days	Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.
Blood Pressures of Subjects From Baseline to Day 35	Day 0 - 35	Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \[BP\]). Descriptive statistics performed by dose group and visit.
Heart Rates of Subjects From Baseline to Day 35	Day 0-35	Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.
Respiratory Rates of Subjects From Baseline to Day 35	Day 0-35	Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.
Temperatures of Subjects From Baseline to Day 35	Day 0-35	Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).