Healthy Adult SubjectsNCT04433208
Dietary Supplement With and Without a Probiotic
A study testing Complex oligosaccharide, Probiotic and PPI in people with Healthy Adult Subjects, 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 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Complex oligosaccharide, Probiotic and PPI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 2 Dec 2020
- Phase
- Interventional
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Study of a Complex Oligosaccharide With and Without a Probiotic 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. 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.
- Conditions
- Healthy Adult Subjects
- Being tested
- Complex oligosaccharide, Probiotic, PPI, H2 Blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex oligosaccharideDietary supplement
Complex oligosaccharide concentrate
ProbioticDietary supplement
Probiotic
PPIOther
Over-the-counter proton pump inhibitor (PPI)
H2 BlockerOther
Over-the-counter H2 blocker
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Probiotic) | Experimental | Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily Receives: Dietary Supplement: Probiotic |
| Cohort 2 (Complex oligosaccharide) | Experimental | Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily Receives: Dietary Supplement: Complex oligosaccharide |
| Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic) | Experimental | 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 Receives: Dietary Supplement: Complex oligosaccharide; Dietary Supplement: Probiotic |
| Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic) | Experimental | 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 Receives: Dietary Supplement: Complex oligosaccharide; Dietary Supplement: Probiotic |
| Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Experimental | 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 Receives: Dietary Supplement: Complex oligosaccharide; Dietary Supplement: Probiotic; Other: PPI; Other: H2 Blocker |
| Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic) | Experimental | 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 Receives: Dietary Supplement: Complex oligosaccharide; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.
Measured: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57
Secondary outcomes (5)
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Measured: Day 1 - 15
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA).
Measured: Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 \& 6 combined; 18g HMO + B.
infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples.
Measured: Day 1, 8, 15, 29
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Measured: Day 1 - 15
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose.
Measured: Day 1 - 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start13 Mar 2020
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
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 Adult SubjectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT04433208
- Sponsor's protocol ID
- 20-CT-001
- Status last verified
- Feb 2025
- First submitted
- 29 May 2020
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 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 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04433208
- Acronym / sponsor ID
- 20-CT-001
- Conditions
- Healthy Adult Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 18 Mar 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. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Probiotic) | Experimental | Dietary Supplement: ProbioticDay 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily |
| Cohort 2 (Complex oligosaccharide) | Experimental | Dietary Supplement: Complex oligosaccharideDay 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily |
| Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic) | Experimental | Dietary Supplement: Complex oligosaccharide, Dietary Supplement: ProbioticDay 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 |
| Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic) | Experimental | Dietary Supplement: Complex oligosaccharide, Dietary Supplement: ProbioticDay 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 |
| Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Experimental | Dietary Supplement: Complex oligosaccharide, Dietary Supplement: Probiotic, Other: PPI, Other: H2 BlockerFirst 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 |
| Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic) | Experimental | Dietary Supplement: Complex oligosaccharide, Dietary Supplement: ProbioticDay 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Complex oligosaccharideComplex oligosaccharide concentrate | Dietary supplement | Cohort 2 (Complex oligosaccharide), Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic), Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic), Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker), Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic) |
| ProbioticProbiotic | Dietary supplement | Cohort 1 (Probiotic), Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic), Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic), Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker), Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic) |
| PPIOver-the-counter proton pump inhibitor (PPI) | Other | Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker) |
| H2 BlockerOver-the-counter H2 blocker | Other | Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker) |
Primary outcome
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
Time frame: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57
qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.
5 secondary outcomes
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Time frame: Day 1 - 15
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Time frame: Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Time frame: Day 1, 8, 15, 29
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)
Time frame: Day 1 - 15
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)
Time frame: Day 1 - 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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?
A study testing Complex oligosaccharide, Probiotic and PPI in people with Healthy Adult Subjects, 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 3 inclusion and 11 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 18 Mar 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 18 Mar 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 Levels of B.Infantis in Stool by Quantitative PCR (time frame: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57). 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 18 Mar 2025.