Consumer Health Study Aims to Evaluate the Safety, Tolerability and Impact of ED02 Probiotic Supplement on Gastrointestinal Outcomes
NCT07423897 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-04-01
Summary
The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the Study Team indicates that this strain lacks harmful genetic traits and can successfully mitigate infections from hypervirulent pathogens like Klebsiella pneumoniae without adverse effects.
Conditions
- Gastrointestinal
- Gut Health
Interventions
- DIETARY_SUPPLEMENT
-
Bifidobacterium pseudocatenulatum
Probiotic Supplement
- DIETARY_SUPPLEMENT
-
Placebo
Matching placebo
Sponsors & Collaborators
-
People Science, Inc.
collaborator INDUSTRY -
Synbiotic Health
lead INDUSTRY
Principal Investigators
-
Noah Craft, M.D., Ph.D. · People Science, Inc.
-
Azure Grant · People Science, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-02
- Primary Completion
- 2026-06-17
- Completion
- 2026-08-31
Countries
- United States
Study Locations
More Related Trials
-
A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study
NCT05614726 ·Status: COMPLETED ·Phase: NA
-
A Study of the Effects of Probiotics in Children Grades 1-3
NCT00635388 ·Status: COMPLETED ·Phase: NA
-
Prospective Tolerability Assessment of a Probiotic Dietary Supplement
NCT04044144 ·Status: COMPLETED ·Phase: NA
-
Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
NCT00796393 ·Status: COMPLETED ·Phase: NA
-
Infant Microbiota and Probiotic Intake Study
NCT02457338 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Efficacy and Safety of Probiotic Products for Digestive Health
NCT06385639 ·Status: RECRUITING ·Phase: NA
-
A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
NCT02950012 ·Status: COMPLETED ·Phase: PHASE2
-
Probiotics and Multi-Drug Resistant Urinary Tract Infection
NCT03644966 ·Status: COMPLETED ·Phase: NA
-
Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
NCT02086110 ·Status: COMPLETED ·Phase: NA
-
Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
NCT03611647 ·Status: COMPLETED ·Phase: NA
-
Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms
NCT05564767 ·Status: COMPLETED ·Phase: NA
-
The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation
NCT01879098 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids
NCT01716910 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms
NCT05845073 ·Status: COMPLETED ·Phase: NA
-
Safety, Tolerability and Host Response to Lactobacillus Johnsonii
NCT02349360 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Determination of the Safety and Efficacy of Two Probiotic Strains
NCT06466174 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Efficacy of Bifidobacterium Lactis CCT 7858 in Adults Using Antibiotics
NCT04742322 ·Status: COMPLETED ·Phase: PHASE2
-
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
NCT01087892 ·Status: COMPLETED ·Phase: NA
-
Research on the Role of Probiotics in Human Intestinal Health
NCT06886711 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Probiotics in Hospitalized Patients Study
NCT01596153 ·Status: WITHDRAWN ·Phase: NA
-
Probiotics to Promote Intestinal Health
NCT02046512 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
NCT01652066 ·Status: COMPLETED ·Phase: NA
-
Evaluating the Ability of a Multi-Strain Postbiotic to Impact Inflammation, Immune Components, Gastrointestinal Symptoms, Recovery, Anxiety, and Intestinal Permeability
NCT07387991 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Effect of Synbiotics on the Upper Respiratory Tract Infection
NCT04960878 ·Status: COMPLETED ·Phase: NA
-
Probiotics on Stress-associated Gastrointestinal Function in University Students
NCT03056846 ·Status: COMPLETED ·Phase: NA