An observational study in Moderate Gastrointestinal Discomfort, sponsored by Biohm Technologies. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Biohm Technologies · Observational
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.
Digestive health has garnered significant attention among consumers as evidenced by the 2012 National Health Initiative Survey (NHIS) reporting approximately 4 million adults using dietary supplements aimed at enhancing digestive wellness. Probiotics which are beneficial bacteria and yeast primarily residing in the gastrointestinal tract are available as dietary supplements and are present in naturally occurring foods such as yogurt, kefir, sauerkraut, tempeh and kimchi. Previous research indicates improved digestive health, immune boosting and improved mental health, yet further investigation is warranted. This study aims to assess the impact of oral supplementation with a probiotic blend on gastrointestinal symptoms and alterations in microbiome composition.
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 colony forming units (CFU) to 1 Billion colony forming units (CFU). The probiotic blend consists of Lactobacillus acidophilus, Lactobacillus rhamnosus, Saccharomyces boulardii, Bifidobacterium breve and amylase. The blend is manufactured at Current Good Manufacturing Practice (cGMP) facilities located in the United States and has attained self Generally Recognized as Safe (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 Food Allergen Labeling and Consumer Protection Act (FALCPA) panel of allergens ensuring there are no allergens present in the blend.
BIOHM FX has previously been studied to show a number of digestive health-related properties such as supporting healthy digestion, reduced bloating, flatulence, abdominal pain and constipation. Additionally BIOHM FX has been shown to break down polymicrobial biofilms, and support healthy candida levels.
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 over 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.
The study team will examine the outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home stool collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and at-home sample collection. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.
This is the only study on the registry with Biohm Technologies as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Healthy Individuals with Moderate Gastrointestinal Discomfort
Exclusion Criteria:
Concomitant Therapies:
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:
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
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
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 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.
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.
Time frame: 6 weeks
To assess the effect of two different doses of BIOHM FX Probiotic blend on gut microbiome markers
Change in gut microbiome, specifically in probiotic species of bacteria and fungi between placebo and study product groups at Week 6 as analyzed and measured from stool specimens. Baseline period will be compared as well as changes between the two doses. There are no minimum and maximum values as stool samples will be analyzed.
Time frame: 6 weeks
To assess the effect of two different doses of BIOHM FX Probiotic blend on anxiety
Change in Anxiety Symptom Questionnaire (ASQ) score at Week 6 between placebo and study product groups. Baseline period will be compared as well as scores between the two doses. Each item on the Anxiety Symptom Questionnaire is rated on a 10-point scale, assessing both the intensity and frequency of anxiety symptoms. Higher scores on the Anxiety Symptom Questionnaire indicate greater anxiety severity.
Time frame: 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)
Change in gut microbiome, specifically in opportunistic pathogenic species of bacteria and fungi at Week 6 between placebo and study product groups as analyzed and measured from stool specimens. Baseline period will be compared as well as changes between the two doses. There are no minimum and maximum values as stool samples will be analyzed.
Time frame: 6 weeks
To assess the effect of two different doses of BIOHM FX Probiotic blend on quality of life
Change in average scores of gastrointestinal symptoms (i.e flatulence, bloating, abdominal discomfort, stool consistency/ regularity, constipation) between placebo and study product groups as measured by daily survey questions. Baseline period will be compared as well as scores between the two doses. Change in the Short Form (SF-36) Survey, a health-related quality of life, score at Week 6 between placebo and study product groups. Baseline period will be compared as well as scores between the two doses. The Short Form (SF-36) Survey score is a number between 0 and 100, with higher scores indicating better health. A score of 0 indicates maximum disability, while a score of 100 indicates no disability.
Time frame: 6 weeks
To observe the safety and tolerability of two different doses of BIOHM FX Probiotic blend
Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and adverse event withdrawals reported over the study product/placebo use period. There are no minimum and maximum values for adverse events, the more and/or serious the adverse event the worse the outcome.
Time frame: 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.