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ACTIVE NOT RECRUITING
NCT06782945

Investigating the Effectiveness of 2 Different Doses of BIOHM FX Probiotic Blend in Improving Digestive Symptoms

Sponsor: Biohm Technologies

View on ClinicalTrials.gov

Summary

The rationale for this study is to observe the effect of two different doses of a consumer-grade probiotic product called FX Probiotic Blend on digestive symptoms in individuals with moderate gastrointestinal discomfort. Additionally, the study aims to observe the effects of the probiotic product on anxiety and quality of life, as well as effects on gut microbiota via activities and technologies that can successfully and effectively be completed and utilized in a home setting. Because this product is currently available in the overt the counter (OTC) market across the United States, a consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this probiotic product in this population.

Official title: A Direct-to-Consumer Placebo-controlled Study Investigating the Effectiveness of 2 Different Doses of BIOHM FX Probiotic Blend in Improving Digestive Symptoms in Individuals With Moderate Gastrointestinal Discomfort

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

141

Start Date

2024-07-24

Completion Date

2025-03-04

Last Updated

2025-01-20

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

BIOHM FX Probiotic Blend

BIOHM Health has been selling BIOHM FX, a blend of probiotics as a dietary supplement addressed at the digestive health market since 2017. The blend is present in the market in various concentrations ranging from 30 Billion CFU to 1 Billion CFU. The probiotic blend consists of Lactobacillus acidophilus, Lactobacillus rhamnosus, Saccharomyces boulardii, Bifidobacterium breve and amylase. The blend is manufactured at cGMP facilities located in the United States and has attained self GRAS status. Prior to release, each lot of probiotic blend is tested for heavy metals, objectionable organisms, water content, probiotic potency, enzyme activity level and allergens, Soy, Milk and Gluten. Additionally, BIOHM performs annual testing for a full FALCPA panel of allergens ensuring there are no allergens present in the blend.

Locations (1)

People Science, Inc.

Los Angeles, California, United States