Healthy AdultsNCT05141903
Dietary Supplement With and Without a Probiotic and/or Antibiotic
An observational study of Healthy Adults, run by Prolacta Bioscience at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Antibiotic, HMO Concentrate and Probiotic
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2021to 9 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Healthy Adults, ages 18-75.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Study of a Complex Oligosaccharide With and Without a Probiotic Following Antibiotic Treatment in Healthy Volunteers
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.
- Conditions
- Healthy Adults
- Being tested
- Antibiotic, HMO Concentrate, Probiotic, Food Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDietary supplement
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
HMO ConcentrateDietary supplement
Concentrated milk fortifiers from donor human milk
ProbioticDietary supplement
- infantis
Food SupplementDietary supplement
Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | D1-D5: Antibiotics (3x daily) Receives: Dietary Supplement: Antibiotic | |
| Arm 2 | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily) Receives: Dietary Supplement: Antibiotic; Dietary Supplement: HMO Concentrate; Dietary Supplement: Probiotic | |
| Arm 3 | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic Receives: 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) Receives: 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) Receives: Dietary Supplement: Antibiotic; Dietary Supplement: Probiotic; Dietary Supplement: Food Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day, 5, 14, 35
Secondary outcomes (5)
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.
Measured: Baseline-28 days
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.
Measured: Day 0 - 35
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.
Measured: Day 0-35
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.
Measured: Day 0-35
Temperatures of Subjects From Baseline to Day 35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).
Measured: Day 0-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start21 Sep 2021
- Primary completion23 May 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolacta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141903
- Sponsor's protocol ID
- 21-CT-003
- Status last verified
- Jan 2025
- First submitted
- 19 Nov 2021
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Study of a Complex Oligosaccharide With and Without a Probiotic Following Antibiotic Treatment in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05141903
- Acronym / sponsor ID
- 21-CT-003
- Conditions
- Healthy Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Dietary Supplement: AntibioticD1-D5: Antibiotics (3x daily) |
| Arm 2 | – | Dietary Supplement: Antibiotic, Dietary Supplement: HMO Concentrate, Dietary Supplement: ProbioticD1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily) |
| Arm 3 | – | Dietary Supplement: Antibiotic, Dietary Supplement: ProbioticD1-D5: Antibiotics (3x daily) D1-D14: Probiotic |
| Arm 4 | – | Dietary Supplement: Antibiotic, Dietary Supplement: HMO Concentrate, Dietary Supplement: Probiotic, Dietary Supplement: Food SupplementD1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily) |
| Arm 5 | – | Dietary Supplement: Antibiotic, Dietary Supplement: Probiotic, Dietary Supplement: Food SupplementD1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy Adults, ages 18-75.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticVancomycin (250 mg/dose), Metronidazole (500 mg/dose) | Dietary supplement | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| HMO ConcentrateConcentrated milk fortifiers from donor human milk | Dietary supplement | Arm 2, Arm 4 |
| ProbioticB. infantis | Dietary supplement | Arm 2, Arm 3, Arm 4, Arm 5 |
| Food SupplementSynthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT) | Dietary supplement | Arm 4, Arm 5 |
Primary outcome
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Time frame: 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.
5 secondary outcomes
Changes in Immune Markers Assessment at Day 5, 14 and 28
Time frame: Baseline-28 days
Blood Pressures of Subjects From Baseline to Day 35
Time frame: Day 0 - 35
Heart Rates of Subjects From Baseline to Day 35
Time frame: Day 0-35
Respiratory Rates of Subjects From Baseline to Day 35
Time frame: Day 0-35
Temperatures of Subjects From Baseline to Day 35
Time frame: Day 0-35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults, run by Prolacta Bioscience at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) (time frame: Baseline, Day, 5, 14, 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.