Safety Study of Human Milk Oligosaccharides in Healthy Adults

Healthy Clinical Trial

Official title:

Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516225
• Other study ID #: 16-CLN-003
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2016
• Est. completion date: February 13, 2017

Study information

• Verified date: August 2022
• Source: Prolacta Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 13, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Lactose intolerance

• Pregnancy

• Lactation

• Enrollment in another clinical study

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PBCLN-003
Human Milk Oligosaccharide Concentrate

Locations

Country	Name	City	State
United States	WCCT Global, LLC	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Prolacta Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	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.	28 days
Secondary	Serum cytokine levels	IL2, IL4, IL5, IL6, IL10, IL12, TNFa, IFN?, and TGFß measured by ELISA	28 days