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Safety and Tolerance of a Novel Three-Strain Probiotic in Healthy Adults

NCT07566884 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-11

No results posted yet for this study

Summary

This Phase I \& II study evaluates the safety and tolerability of 8 weeks of daily supplementation with high-dose versus standard-dose of a novel three-strain probiotic. Safety and tolerability will be assessed by adverse events, safety blood profile, and vital signs. Secondary assessments include food cravings, gastrointestinal outcomes, sleep, quality of life, subjective ratings of hunger and satiety and associated hormone responses including plasma GLP-1, glucose, and insulin.

Conditions

  • Healthy Adults

Interventions

DIETARY_SUPPLEMENT

Three-Strain Probiotic

≥ 500 million AFU of Clostridium butyricum strain WB-STR-0006, Akkermansia muciniphila strain WB-STR-0001, Bifidobacterium infantis Bi-26TM, 174 mg chicory inulin (prebiotic), 19mg Microcrystalline Cellulose MCC, 4mg L-Leucine, and 3mg Silica (excipients) to be taken once daily with food

DIETARY_SUPPLEMENT

Phase 2 - Placebo

Phase 2 - Matching Placebo

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • APC Microbiome Ireland

    collaborator UNKNOWN

  • Pendulum Therapeutics

    lead INDUSTRY

Principal Investigators

  • Adam Perlman, MD, MPH · Pendulum Therapeutics, Inc

  • Noel Caplice, MD · APC Microbiome Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2028-01-31
Completion
2028-04-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566884 on ClinicalTrials.gov