HealthyPhase 1NCT05516225
Safety Study of Human Milk Oligosaccharides in Healthy Adults
A Phase 1 study testing PBCLN-003 in people with Healthy, run by Prolacta Bioscience at 1 site in United States.
Trial summary
First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PBCLN-003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2016to 13 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
- Age between 18 and 50 years old
- No diagnosed medical conditions
- No significant change to diet in the 2 weeks prior to enrollment
- Agreement to use contraception for female subjects
Who cannot join
- Lactose intolerance
- Pregnancy
- Lactation
- Enrollment in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers
First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).
- Conditions
- Healthy
- Being tested
- PBCLN-003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBCLN-003Drug
Human Milk Oligosaccharide Concentrate
| Study group | Role | What they receive |
|---|---|---|
| PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days | Experimental | Not described Receives: Drug: PBCLN-003 |
| PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days | Experimental | Not described Receives: Drug: PBCLN-003 |
| PBCLN-003, 9 g daily in 3 divided oral doses for 7 days | Experimental | Not described Receives: Drug: PBCLN-003 |
| PBCLN-003, 18 g daily in 3 divided oral doses for 7 days | Experimental | Not described Receives: Drug: PBCLN-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Adverse events include those reported by questionnaire or detected as an abnormality on physical examination, laboratory testing (hematology, biochemistry, urinalysis), and 12-lead electrocardiogram.
Measured: 28 days
Secondary outcomes (2)
Stool, saliva, and vaginal microbiome
16S ribosomal RNA gene sequencing and shotgun metagenomics will be performed to detect relative abundances of bacteria at the level of 97% operational taxonomic units. Alpha diversity will be measured using the Shannon index.
Measured: 28 days
Serum cytokine levels
IL2, IL4, IL5, IL6, IL10, IL12, TNFα, IFNγ, and TGFβ measured by ELISA
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start29 Sep 2016
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT05516225
- Sponsor's protocol ID
- 16-CLN-003
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jacobs JP, Lee ML, Rechtman DJ, Sun AK, Autran C, Niklas V. Human milk oligosaccharides modulate the intestinal microbiome of healthy adults. Sci Rep. 2023 Aug 31;13(1):14308. doi: 10.1038/s41598-023-41040-5.
PubMed 37652940
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05516225
- Acronym / sponsor ID
- 16-CLN-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days | Experimental | Drug: PBCLN-003 |
| PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days | Experimental | Drug: PBCLN-003 |
| PBCLN-003, 9 g daily in 3 divided oral doses for 7 days | Experimental | Drug: PBCLN-003 |
| PBCLN-003, 18 g daily in 3 divided oral doses for 7 days | Experimental | Drug: PBCLN-003 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
- Age between 18 and 50 years old
- No diagnosed medical conditions
- No significant change to diet in the 2 weeks prior to enrollment
- Agreement to use contraception for female subjects
Key exclusion criteria (4 listed)
- Lactose intolerance
- Pregnancy
- Lactation
- Enrollment in another clinical 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 |
|---|---|---|
| PBCLN-003Human Milk Oligosaccharide Concentrate | Drug | PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days, PBCLN-003, 18 g daily in 3 divided oral doses for 7 days, PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days, PBCLN-003, 9 g daily in 3 divided oral doses for 7 days |
Primary outcome
Number of Adverse Events
Time frame: 28 days
Adverse events include those reported by questionnaire or detected as an abnormality on physical examination, laboratory testing (hematology, biochemistry, urinalysis), and 12-lead electrocardiogram.
2 secondary outcomes
Stool, saliva, and vaginal microbiome
Time frame: 28 days
Serum cytokine levels
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 37652940Jacobs JP, Lee ML, Rechtman DJ, Sun AK, Autran C, Niklas V. Human milk oligosaccharides modulate the intestinal microbiome of healthy adults. Sci Rep. 2023 Aug 31;13(1):14308. doi: 10.1038/s41598-023-41040-5.
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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 Phase 1 study testing PBCLN-003 in people with Healthy, 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 5 inclusion and 4 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 25 Aug 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516225, which also lists 1 linked publication.
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 25 Aug 2022.