Postbiotic for Oral Health

(LOOFAH2 Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Archer-Daniels-Midland Company

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomised, placebo-controlled trial is to determine the effect of a chewable postbiotic tablet on the oral health of male and female healthy adults under conditions of short term oral-neglect (a short, temporary period during which participants do not perform their usual oral hygiene practices, such as tooth brushing and flossing).

The main questions the study aims to answer are:

1. Does postbiotic ingestion impact dental plaque accumulation, gingival (gum) inflammation, and periodontal health compared with placebo?

2. Does postbiotic ingestion alter the oral microbiome composition compared with placebo?

Are You a Good Fit for This Trial?

This trial is for healthy adult men and women who are willing to temporarily stop their usual oral hygiene routines, like brushing and flossing, for a short period. People with existing health issues or dental problems may not be eligible.

Inclusion Criteria

Body mass index (BMI) between 18.5 to 29.9 kg/m^2 (inclusive)
In otherwise good general health as deemed by investigator based on medical history, vital signs, and physical examination
Able to consume the study product completely within the specified timeframe
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Exclusion Criteria

Clinically significant illness during 28 days before first dose
History of alcohol or substance abuse within 24 months prior to screening including recreational drug use, nicotine dependence, high-risk alcohol consumption, hospitalization for abuse, or any use concerning investigator
Dental prosthetic or orthodontic devices likely to interfere with study outcomes as per investigator discretion
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What Are the Treatments Tested in This Trial?

Interventions

  • Postbiotic

Trial Overview

The study compares the effects of a chewable postbiotic tablet versus a placebo on oral health during a brief time when participants neglect regular mouth care. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PostbioticExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Archer-Daniels-Midland Company

Lead Sponsor

Trials
17
Recruited
1,400+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials
40
Recruited
2,400+