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CompletedNCT05141903Updated Feb 17, 2025Results posted

Dietary Supplement With and Without a Probiotic and/or Antibiotic

An observational study in Healthy Adults, sponsored by Prolacta Bioscience. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Prolacta Bioscience · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
92
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Adults
03

In context

Lead sponsor

Prolacta Bioscience is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy Adults, ages 18-75.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
92 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Dietary supplementAntibiotic

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

  • Dietary supplementHMO Concentrate

    Concentrated milk fortifiers from donor human milk

  • Dietary supplementProbiotic

    B. infantis

  • Dietary supplementFood Supplement

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

06

What researchers measure

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.

    Time frame: Baseline, Day, 5, 14, 35

Secondary outcomes

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

    Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.

    Time frame: Baseline-28 days

  2. Blood Pressures of Subjects From Baseline to Day 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.

    Time frame: Day 0 - 35

  3. Heart Rates of Subjects From Baseline to Day 35

    Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.

    Time frame: Day 0-35

  4. Respiratory Rates of Subjects From Baseline to Day 35

    Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.

    Time frame: Day 0-35

  5. Temperatures of Subjects From Baseline to Day 35

    Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).

    Time frame: Day 0-35

07

Results

Posted Feb 17, 2025

Participant flow

Participant flow — Overall Study
MilestoneAntibiotics AloneAntibiotics, Probiotic, HMOAntibiotics ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, Food
Started1919181818
Completed1817171818
Not completed12100
Withdrew: Withdrawal by subject01100
Withdrew: Other11000

Outcome measures

PrimaryEvaluation 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.

Time frame:
Baseline, Day, 5, 14, 35
Reported as:
Geometric mean · copies/ng DNA
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
copies/ng DNAAntibiotics AloneAntibiotics, Probiotics, HMOAntibiotics ProbioticsAntibiotics, Probiotics, HMO, FoodAntibiotics, Probiotics, Food
Baseline27.00 ± 0.0031.25 ± 82.2727.00 ± 0.0027.00 ± 0.0027.00 ± 0.00
Day 527.00 ± 0.00383.41 ± 862.67535.35 ± 708.21204.11 ± 312.05431.26 ± 883.43
Day 1428.08 ± 6.8726877.59 ± 69845.621868.09 ± 10150.7321736.64 ± 50622.1445466.96 ± 81975.89
Day 3527.00 ± 0.00311.22 ± 14917.8177.15 ± 1857.2588.78 ± 1249.73170.03 ± 5638.54
Statistical analysis
  • Antibiotics Alone vs Antibiotics, Probiotics, HMO · Mixed Models Analysis · p = <0.0001 ((Dose group \* Time))Dfn, Dfd = 11, 369 F Value = 24.31
  • Antibiotics Alone vs Antibiotics Probiotics · Mixed Models Analysis · p = <0.0001 (Dose group \* Time)Dfn, Dfd = 11, 370 F value = 14.87
  • Antibiotics, Probiotics, HMO vs Antibiotics Probiotics · Mixed Models Analysis · p = <0.0001 (Dose Group \* Time)Dfn, Dfd = 11, 351 F value = 8.606
SecondaryChanges in Immune Markers Assessment at Day 5, 14 and 28

Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.

Time frame:
Baseline-28 days
Reported as:
Mean · ng/mL
Changes in Immune Markers Assessment at Day 5, 14 and 28
ng/mLAntibiotics AloneAntibiotics, Probiotic, HMO
LAP-TGFB - baseline34.3 ± 8.137.6 ± 9.6
LAP-TGFB - Day 534.3 ± 7.734.6 ± 7.8
LAP-TGFB - Day 1429.7 ± 9.034.7 ± 8.1
LAP-TGFB - Day 2830.2 ± 9.332.9 ± 5.9
MCP1 - Baseline405.6 ± 211.3399.7 ± 253.3
MCP1 - Day 5416.6 ± 214.0401.8 ± 215.5
MCP1 - Day 14476.8 ± 243.8411.1 ± 199.1
MCP1 - Day 28464.3 ± 250.6433.8 ± 187.3
MIP - Baseline385.7 ± 106.9358.2 ± 228.7
MIP - Day 5429 ± 129.9391.9 ± 231.0
MIP - Day 14383.6 ± 226.1361.6 ± 224.2
MIP - Day 28315.1 ± 134.5322.0 ± 226.7
SecondaryBlood Pressures of Subjects From Baseline to Day 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.

Time frame:
Day 0 - 35
Reported as:
Mean · mmHg
Blood Pressures of Subjects From Baseline to Day 35
mmHgAntibiotics AloneAntibiotics, Probiotic, HMOAntibiotics ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, Food
Systolic Blood Pressure (mmHg) - Baseline123 ± 13.8125 ± 19127 ± 15.2117 ± 11121 ± 15.6
Systolic Blood Pressure (mmHg) - Day 35128 ± 16.6127 ± 17.3130 ± 18.7121 ± 14.8120 ± 18.1
Diastolic Blood Pressure (mmHg) - Baseline75 ± 5.677 ± 11.776 ± 9.771 ± 8.573 ± 7.9
Diastolic Blood Pressure (mmHg) - Day 3575 ± 7.474 ± 1077 ± 12.173 ± 1071 ± 10.3
SecondaryHeart Rates of Subjects From Baseline to Day 35

Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.

Time frame:
Day 0-35
Reported as:
Mean · beats per minute
Heart Rates of Subjects From Baseline to Day 35
beats per minuteAntibiotics AloneAntibiotics, Probiotic, HMOAntibiotic, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, Food
Heart rate - Baseline66 ± 10.966 ± 8.768 ± 8.170 ± 11.971 ± 7.4
Heart rate - Day 3569 ± 10.972 ± 16.273 ± 11.166 ± 11.968 ± 10.1
SecondaryRespiratory Rates of Subjects From Baseline to Day 35

Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.

Time frame:
Day 0-35
Reported as:
Mean · breaths per minute
Respiratory Rates of Subjects From Baseline to Day 35
breaths per minuteAntibiotics AloneAntibiotics, Probiotic, HMOAntibiotic, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, Food
Respirations - Baseline15 ± 1.615 ± 1.115 ± 1.215 ± 1.016 ± 1.2
Respirations - Day 3515 ± 1.115 ± 1.415 ± 1.715 ± 1.114 ± 0.9
SecondaryTemperatures of Subjects From Baseline to Day 35

Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).

Time frame:
Day 0-35
Reported as:
Mean · deg C
Temperatures of Subjects From Baseline to Day 35
deg CAntibiotics AloneAntibiotics, Probiotic, HMOAntibiotic, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, Food
Temperature - Baseline36.8 ± 0.2136.7 ± 0.2436.9 ± 0.2436.8 ± 0.2836.9 ± 0.22
Temperature - Day 3536.9 ± 0.1436.8 ± 0.1936.8 ± 0.1336.8 ± 0.2836.8 ± 0.28

Adverse events

Collected over up to 7 weeks (D1 through D35). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 10/19 (0%)0/19 (0%)4/19 (21.1%)
Arm 20/19 (0%)0/19 (0%)4/19 (21.1%)
Arm 30/18 (0%)0/18 (0%)6/18 (33.3%)
Arm 40/18 (0%)0/18 (0%)7/18 (38.9%)
Arm 50/18 (0%)0/18 (0%)2/18 (11.1%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventArm 1Arm 2Arm 3Arm 4Arm 5
DiarrheaGastrointestinal disorders1/193/191/181/182/18
Abdominal DiscomfortGastrointestinal disorders1/190/190/182/180/18
NauseaGastrointestinal disorders0/190/190/182/180/18
RashSkin and subcutaneous tissue disorders1/190/192/180/180/18
Abdominal DistensionGastrointestinal disorders0/191/191/180/180/18
GI HypermotilityGastrointestinal disorders0/190/190/181/180/18
VomitingGastrointestinal disorders0/190/190/181/180/18
Drug HypersensitivityImmune system disorders0/190/190/181/180/18
COVID-19Infections and infestations0/190/191/180/180/18
SARS-COV-2 Test PositiveInvestigations0/190/191/180/180/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Antibiotics AloneAntibiotics, Probiotic, HMOAntibiotics, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, FoodTotal
<=18 years000011
Between 18 and 65 years141814161678
>=65 years5142113
Sex: Female, Male
Sex: Female, Male(Participants)Antibiotics AloneAntibiotics, Probiotic, HMOAntibiotics, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, FoodTotal
Female126771042
Male7131111850
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Antibiotics AloneAntibiotics, Probiotic, HMOAntibiotics, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, FoodTotal
Hispanic or Latino5555424
Not Hispanic or Latino141413131468
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Antibiotics AloneAntibiotics, Probiotic, HMOAntibiotics, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, FoodTotal
American Indian or Alaska Native000101
Asian1457320
Native Hawaiian or Other Pacific Islander000000
Black or African American3230210
White131110101155
More than one race000000
Unknown or Not Reported220026
Region of Enrollment
Region of Enrollment(participants)Antibiotics AloneAntibiotics, Probiotic, HMOAntibiotics, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, FoodTotal
United States191918181892
Baseline Levels of B. Infantis
Baseline Levels of B. Infantis(copies/ng DNA)Antibiotics AloneAntibiotics, Probiotic, HMOAntibiotics, ProbioticAntibiotics, Probiotic, HMO, FoodAntibiotics, Probiotic, FoodTotal
Mean27.00 ± 0.0031.25 ± 82.2727.00 ± 0.0027.00 ± 0.0027.00 ± 0.0027.8 ± 36.2
08

Study locations

1 site
  • Altasciences
    Cypress, California 90630, United States
09

References and documents

Study documents

  • Study protocol · Apr 22, 2022
  • Statistical analysis plan · Jun 15, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05141903
Lead sponsor
Prolacta Bioscience
Responsible party
Sponsor
First posted
Dec 2, 2021
Start date
Sep 21, 2021
Primary completion
May 23, 2022
Completion
Jun 9, 2022
Results posted
Feb 17, 2025
Last update
Feb 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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