Dietary Supplement With and Without a Probiotic and/or Antibiotic

NCT05141903 | Completed Results

• 1 other identifier: 21-CT-003
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 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.

  Baseline, Day, 5, 14, 35

Secondary Outcomes (5)

• Changes in Immune Markers Assessment at Day 5, 14 and 28

  Baseline-28 days

• Blood Pressures of Subjects From Baseline to Day 35

  Day 0 - 35

• Heart Rates of Subjects From Baseline to Day 35

  Day 0-35

• Respiratory Rates of Subjects From Baseline to Day 35

  Day 0-35

• Temperatures of Subjects From Baseline to Day 35

  Day 0-35

Study Arms (5)

Arm 1

D1-D5: Antibiotics (3x daily)

Dietary Supplement: Antibiotic

Arm 2

D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily)

Dietary Supplement: Antibiotic; Dietary Supplement: HMO Concentrate; Dietary Supplement: Probiotic

Arm 3

D1-D5: Antibiotics (3x daily) D1-D14: Probiotic

Dietary Supplement: Antibiotic; Dietary Supplement: Probiotic

Arm 4

D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily)

Dietary Supplement: Antibiotic; Dietary Supplement: HMO Concentrate; Dietary Supplement: Probiotic; Dietary Supplement: Food Supplement

Arm 5

D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily)

Dietary Supplement: Antibiotic; Dietary Supplement: Probiotic; Dietary Supplement: Food Supplement

Interventions

Antibiotic DIETARY_SUPPLEMENT

Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

HMO Concentrate DIETARY_SUPPLEMENT

Concentrated milk fortifiers from donor human milk

Arm 2; Arm 4

Probiotic DIETARY_SUPPLEMENT

B. infantis

Arm 2; Arm 3; Arm 4; Arm 5

Food Supplement DIETARY_SUPPLEMENT

Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)

Arm 4; Arm 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Adults, ages 18-75.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolacta Bioscience: lead

Study Sites (1)

Altasciences

Cypress, California, 90630, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Urine, and Stool

MeSH Terms

Interventions

Anti-Bacterial Agents; Probiotics; Dietary Supplements

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. David Rechtman VP, Medical Affairs
• Organization: Prolacta Bioscience

drechtman@prolacta.com

8887765228

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: September 21, 2021
• Primary Completion: May 23, 2022
• Study Completion: June 9, 2022
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Locations

US (1)