Moderate Gastrointestinal DiscomfortNCT06782945
Investigating the Effectiveness of 2 Different Doses of BIOHM FX Probiotic Blend in Improving Digestive Symptoms
An observational study of Moderate Gastrointestinal Discomfort, run by Biohm Technologies at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Gastrointestinal Discomfort
- What is being tested?
- BIOHM FX Probiotic Blend
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to 4 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Individuals with Moderate Gastrointestinal Discomfort
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- --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)
- Gallbladder disease (e.g., cholecystitis, cholelithiasis)
- Gastrointestinal cancer (Colorectal, Intestinal, Stomach, Liver, Gallbladder)
- Participants with a known or suspected gastrointestinal infection, such as:
- Clostridium difficile infection
- Helicobacter pylori infection
- Parasitic infections (e.g., Giardia, Cryptosporidium)
- Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.
- Participants with a history of gastrointestinal bleeding or perforation.
- Currently diagnosed with Alcohol Abuse and/or Substance Use Disorder
- Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
- Willing to practice a reliable method of contraception for the duration of the study
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Moderate Gastrointestinal Discomfort
- Being tested
- BIOHM FX Probiotic Blend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOHM FX Probiotic BlendDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: BIOHM FX Probiotic Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start24 Jul 2024
- Primary completion8 Jan 2025
- Study completion4 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Gastrointestinal DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohm Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782945
- Sponsor's protocol ID
- PS09
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06782945
- Acronym / sponsor ID
- PS09
- Conditions
- Moderate Gastrointestinal Discomfort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Biohm TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 4 Mar 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIOHM FX Probiotic Blend 1 billion CFU | – | Dietary Supplement: BIOHM FX Probiotic BlendParticipants 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. |
| BIOHM FX Probiotic Blend 3 billion CFU | – | Dietary Supplement: BIOHM FX Probiotic BlendParticipants 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. |
| Placebo | – | Dietary Supplement: BIOHM FX Probiotic BlendParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Individuals with Moderate Gastrointestinal Discomfort
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (28 listed)
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- 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:
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOHM FX Probiotic BlendBIOHM 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. | Dietary supplement | BIOHM FX Probiotic Blend 1 billion CFU, BIOHM FX Probiotic Blend 3 billion CFU, Placebo |
Primary outcome
To observe the effect of two different doses of BIOHM FX Probiotic blend on digestive symptoms
Time frame: 6 weeks
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.
5 secondary outcomes
To assess the effect of two different doses of BIOHM FX Probiotic blend on gut microbiome markers
Time frame: 6 weeks
To assess the effect of two different doses of BIOHM FX Probiotic blend on anxiety
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)
Time frame: 6 weeks
To assess the effect of two different doses of BIOHM FX Probiotic blend on quality of life
Time frame: 6 weeks
To observe the safety and tolerability of two different doses of BIOHM FX Probiotic blend
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Gastrointestinal Discomfort, run by Biohm Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the effect of two different doses of BIOHM FX Probiotic blend on digestive symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.