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

NCT06782945 | Active Not Recruiting

• 1 other identifier: PS09
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate Gastrointestinal Discomfort

Outcome Measures

Primary Outcomes (1)

• To observe the effect of two different doses of BIOHM FX Probiotic blend on digestive symptoms

  Change in the Gastrointestinal Symptom Rating Scale (GSRS) score between placebo and study product groups. Baseline period will be compared as well as GSRS scores between the two doses. The score is calculated by using a 7-point Likert scale to rate the frequency and intensity of symptoms experienced over the previous week. A higher score indicates more severe symptoms and worse outcomes.

  6 weeks

Secondary Outcomes (5)

• To assess the effect of two different doses of BIOHM FX Probiotic blend on gut microbiome markers

  6 weeks

• To assess the effect of two different doses of BIOHM FX Probiotic blend on anxiety

  6 weeks

• To assess the effect of two different doses of BIOHM FX Probiotic blend on gastrointestinal symptoms (i.e. flatulence, bloating, abdominal discomfort, stool consistency/ regularity, constipation)

  6 weeks

• To assess the effect of two different doses of BIOHM FX Probiotic blend on quality of life

  6 weeks

• To observe the safety and tolerability of two different doses of BIOHM FX Probiotic blend

  6 weeks

Study Arms (3)

BIOHM FX Probiotic Blend 1 billion CFU

Participants will be randomized to one of 3 groups: (1) BIOHM FX Probiotic Blend 1 billion CFU, (2) BIOHM FX Probiotic Blend 3 billion CFU, and (3) Matching placebo. The Investigators and study team and Participants will be blinded to the group assignment. Screening assessments, questionnaires, scales, surveys, and at-home stool collection during the use of the study product/placebo and end of study experience survey data will be collected.

Dietary Supplement: BIOHM FX Probiotic Blend

BIOHM FX Probiotic Blend 3 billion CFU

Participants will be randomized to one of 3 groups: (1) BIOHM FX Probiotic Blend 1 billion CFU, (2) BIOHM FX Probiotic Blend 3 billion CFU, and (3) Matching placebo. The Investigators and study team and Participants will be blinded to the group assignment. Screening assessments, questionnaires, scales, surveys, and at-home stool collection during the use of the study product/placebo and end of study experience survey data will be collected.

Dietary Supplement: BIOHM FX Probiotic Blend

Placebo

Participants will be randomized to one of 3 groups: (1) BIOHM FX Probiotic Blend 1 billion CFU, (2) BIOHM FX Probiotic Blend 3 billion CFU, and (3) Matching placebo. The Investigators and study team and Participants will be blinded to the group assignment. Screening assessments, questionnaires, scales, surveys, and at-home stool collection during the use of the study product/placebo and end of study experience survey data will be collected.

Dietary Supplement: BIOHM FX Probiotic Blend

Interventions

BIOHM FX Probiotic Blend DIETARY_SUPPLEMENT

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.

BIOHM FX Probiotic Blend 1 billion CFU; BIOHM FX Probiotic Blend 3 billion CFU; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Individuals with Moderate Gastrointestinal Discomfort

You may qualify if:

• Age between 18-75 years old, inclusive
• Has self-reported moderate digestive symptoms, such as abdominal pain, bloating, flatulence, constipation, or diarrhea.
• Has a moderate Gastrointestinal Symptom Rating Scale (GSRS) score between 4-5.
• Willingness to refrain from taking probiotics or prebiotics during the study period.
• Interested in understanding more about their gut health and the use probiotic products
• If taking any OTC or prescription medications for anxiety (e.g. magnesium, anticholinergics, Buspirone, Tricyclics, MAOIs,) or other class of medication for anxiety, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study.
• If using any cannabis-containing products, must be on a stable regimen for at least 4 weeks prior to randomization and throughout the course of the study.
• If using any nicotine-containing products, must be on a stable regimen for at least 4 weeks prior to randomization and throughout the course of the study.
• In good general health at the time of screening (Investigator discretion).
• Able to read and understand English.
• Able to read, understand, and provide informed consent.
• Able to use a personal smartphone device and download Chloe by People Science.
• Able to receive shipment of the product at an address within the United States.
• Able to complete study assessments over the course of up to 7 weeks.

You may not qualify if:

• Do not have a personal smartphone, internet access, or unwilling to download Chloe.
• Concomitant Therapies:
• Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
• Participants currently taking or have taken antibiotics, probiotics, or prebiotics within the past 4 weeks prior to randomization.
• Participants using immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.
• Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
• Participants with a clinical diagnosis of any gastrointestinal illness, including but not limited to:
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• Gastroesophageal reflux disease (GERD)
• Gastric or duodenal ulcers
• Celiac disease
• Diverticular disease
• Chronic pancreatitis
• Gastroparesis
• Severe liver disease (e.g., cirrhosis, hepatitis, NAFLD acceptable)

Sponsors & Collaborators

• Biohm Technologies: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science, Inc.

Los Angeles, California, 90034, United States

Location

Study Officials

• Noah Craft, MD

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: January 20, 2025
• Study Start: July 24, 2024
• Primary Completion: January 8, 2025
• Study Completion: March 4, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

US (1)