N/A
N=62
Dietary Supplement With and Without a Probiotic
Healthy Adult Subjects
Bottom Line
View on ClinicalTrials.gov: NCT04433208 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR — 3.33; 3.33; 3.33; 3.33 copies/ng DNA — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Complex oligosaccharide (Dietary_supplement); Probiotic (Dietary_supplement); PPI (Other); H2 Blocker (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prolacta Bioscience
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR |
3.33; 3.33; 3.33; 3.33; 3.33; 3.33 | <0.0001 sig |
| SECONDARY Changes in Concentration of Blood Parameters From Day 1 to Day 15 |
14.10; 17.36; 16.30; 13.43; 16.82; 16.00 | — |
| SECONDARY Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit |
3.3; 3.3; 263.2; 371.4; 391.7; 1454.3 | — |
| SECONDARY Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 |
0.11; 0.39; 3.18; 0.14; 0.18; 0.20 | — |
| SECONDARY Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) |
354.0; 382.9; 362.3; 358.5; 403.6; 384.2 | — |
| SECONDARY Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) |
71.0; 68.6; 65.1; 65.2; 75.1; 73.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04433208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.