Gastrointestinal HealthNCT05595980
The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults
A study testing Probiotic in people with Gastrointestinal Health and Immune Health, run by BIO-CAT Microbials, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the effect of an oral probiotic (Bacillus sp. spore preparation) on abdominal bloating, flatulence, and burping in generally healthy adults. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health, Immune Health, Digestive Health
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 30-65 years of age, inclusive at Visit 1 (Day -7)
- BMI of 18.50 to 31.99 kg/m^2, inclusive, at Visit 1 (Day -7)
- Have ≥ 3 weekly total symptom score obtained by combining ratings for gas/flatulence, abdominal bloating, and burping symptoms (e.g., 3 days with a mild severity across the three symptoms, 1 day of mild severity and 1 day of moderate severity across the three symptoms, or 1 day of severe severity across the three symptoms)
- Consumes a typical American diet (defined as ≤ 3 servings/d of fruits and vegetables combined and < 3 servings/d of whole grains)
- Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period
- Non-user or former users (cessation ≥ 12 months) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period
Show all 11Show fewer
- Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial
- Willing to limit alcohol consumption to ≤ 2 standard drinks per day throughout the trial
- Willing to refrain from exclusionary medications, supplements, and products throughout the study
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator
Who cannot join
- Known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Abnormal laboratory test results of clinical significance at Visit 1 (Day -7), at the discretion of the Clinical Investigator
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies)
- Pre-menopausal female subject with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to Visit 1)
- Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥ 3 loose or liquid stools/d)
- Self-reported history (within 6 weeks of Visit 1; Day -7) of constipation (defined as fewer than three bowel movements per week)
Show all 28Show fewer
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7)
- Have received a COVID-19 vaccine within 2 weeks of randomization or expected to receive a COVID-19 vaccine during the study period
- Had a positive SARS-CoV2 test and experienced symptoms for > 2 months (i.e. "long-haulers")
- Known allergy, intolerances or sensitivity to milk, soy, or wheat
- Extreme dietary habits at the discretion of the Clinical Investigator
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
- Major trauma or any other surgical event within 3 months of Visit 1 (Day -7)
- Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Day -7)
- Weight loss or gain > 4.5 kg in the 3 months prior to Visit 1 (Day -7)
- Currently or planning to be on a weight loss regimen during the study
- Antibiotic use within 3 months of Visit 1 (Day -7) and throughout the study period
- Use of steroids within 1 month of Visit 1 (Day -7) and throughout the study period
- Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDS) within 1 month of Visit 1 (Day -7)
- Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to, pre- and probiotic supplements as well as foods or beverages containing live probiotics (e.g., yogurt, kombucha), fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 2 weeks of Visit 1 (Day -7) and throughout the study period
- Participated in endoscopy or endoscopy preparation within 3 months prior to Visit 1 (Day -7)
- Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7)
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
- Recent history (within 12 months of screening; Visit 1; Day -7) of alcohol or substance abuse
- Self-report of blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to screening or a blood donation of more than 450 mL within 56 days
- Receipt or use of study products in another research study within 28 days prior to Visit 2 (Day 0) or longer if the previous study product is deemed by the Clinical Investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research, Inc.
Addison, Illinois, 60101
About this study
Official title: A Randomized, Parallel, Double-blind, Placebo-Controlled Study to Investigate the Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults
The primary objective of this study is to investigate the effect of an oral probiotic (Bacillus sp. spore preparation) on abdominal bloating, flatulence, and burping in generally healthy adults. Secondary outcomes include intestinal barrier integrity and fecal microbiome properties (taxonomical structure, diversity, and function).
Read the detailed description
Probiotics are live microbes that, when administered in adequate amounts, confer a health benefit. Examples of probiotic health benefits include the support of gastrointestinal (GI) health and immune health. Common probiotic strains include species from the Bacillaceae family (e.g. Bacillus genus) and Lactobacillaceae family of the Bacillota phylum (formerly Firmicutes), and species from the Bifidobacterium genus of the Actinomycetota phylum (formerly Actinobacteria). Bacillaceae species are particularly advantageous for oral probiotic applications because they can be manufactured as spores with highly proteinaceous coats that persist without refrigeration and resist the acidic and high bile salt conditions that occur across the human GI tract. The objective of this clinical study is to investigate the effects of daily oral supplementation with a novel Bacillus sp. spore preparation for 8 weeks on GI symptoms, intestinal barrier integrity, and fecal microbiome properties.
This will be a randomized, parallel, double-blind, placebo-controlled study consisting of one screening visit (Visit 1, Day -7) and four study visits (Days 0, 1, 57, and 58). At Visit 1 (Day -7), participants will arrive at the clinic in a fasting state (≥ 10 hours). After participants provide voluntary informed consent, participants will undergo medical history, prior and current medication/supplement use, and inclusion and exclusion criteria assessments. Additionally, height, body weight, and vital signs will be measured, and body mass index (BMI) will be calculated. Blood samples will be collected for chemistry, hematology, C-reactive protein (CRP), and insulin analyses. Participants will be dispensed a daily paper Gastrointestinal Tolerance Questionnaire (GITQ) with instructions to capture events occurring during the seven continuous days prior to Visit 2 (Day 0). The paper GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring during the past 24 hours. Therefore, participants will be instructed to complete their first GITQ on the morning of Day -6 and the final GITQ on the morning of Day 0, just before their Visit 2. Additionally, a stool sample collection kit will be dispensed with instructions to a collect stool sample from a single bowel movement (for fecal microbiome analyses) within the 3 days immediately before Visit 2 (Day 0).
At Visit 2 (Day 0), participants will arrive at the clinic in a fasting state (≥ 10 hours). Participants will undergo clinic visit procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight, and vital signs measurements) and adverse event (AE) assessment. Fecal samples will be collected, and subjects will be administered a 7-day recall GITQ. Participants will then undergo an intestinal permeability test where they will ingest four sugar probes (1 g mannitol, 1 g sucralose, 1 g erythritol, and 5 g lactulose) in approximately 240 mL water. Participants will be dispensed 2 separate containers to collect all urine over the following 24 hours, with urine collected from 0 to 5 hours in one container and from 5 to 24 hours in the second container. Participants will be instructed to return both containers to the clinic the following day at Visit 3 (Day 1). Upon completion of the GI permeability test, participants will be randomly assigned to a study product sequence. Participants will receive an email link for an electronic 7-day recall GITQ to be completed on Days 8, 15, 22, 29, 36, 43, 50, and 57. Participants will also receive information regarding daily links that will be sent via email to complete electronic 24-hour recall GITQs and will be instructed to complete these electronic 24-hour GITQs daily starting on day 51, which will be 6 days ahead of Visit 4. Participants will continue recording the 24-hour GITQ recall every day for seven total days (Days 51, 52, 53, 54, 55, 56, and 57). Additionally, a stool sample collection kit will be dispensed with instructions to collect a stool sample from a single bowel movement for fecal microbiome analyses within the 3 days immediately before Visit 4 (Day 57). In addition, a subset of male subjects will be selected to collect an additional fecal sample for fecal metabolomic and/or targeted analyte analyses.
At Visit 3 (Day 1), participants will return the 24-hour urine sample collection containers and undergo AE assessments. Participants will be dispensed their assigned study product and will be instructed to consume it once a day (1 capsule/d) with their meal that is typically the largest of the day for 56 days starting on Day 1.
At Visit 4 (Day 57), participants will arrive at the clinic fasted (≥ 10 hours) and undergo clinic visit procedures, including: concomitant medication/supplement use, review inclusion/exclusion criteria, body weight and vital signs measurements, and AE assessment. Fecal samples will be collected. Blood samples will be collected for chemistry, hematology, CRP, and insulin analyses. Participants will then complete the intestinal permeability test with the same procedures and study instructions described at Visit 2.
At Visit 5 (Day 58), participants will return the 24-hour urine sample collection containers and undergo AE assessments.
- Conditions
- Gastrointestinal Health, Immune Health, Digestive Health
- Being tested
- Probiotic, Placebo
- Keywords
- Bacillus, probiotic, bloating, microbiome, metagenomics, inestinal, permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will consume 1 capsule containing 2 billion CFU of a Bacillus strain spore preparation once daily for 56 days
PlaceboDietary supplement
Participants will consume 1 capsule containing maltodextrin once daily for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Bacillus strain spore preparation Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of abdominal bloating, flatulence, and burping (daily GITQ)
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease (indicating improvement) in the 7-day total composite score of abdominal bloating, flatulence, and burping, from baseline to week 8, where an increase in scores (indicating worsening) cannot occur within any of the 3 symptoms (daily Gastrointestinal Tolerance Questionnaire [GITQ])
Measured: 9 weeks
Secondary outcomes (47)
Composite score of abdominal bloating, flatulence, and burping (7-day recall GITQ)
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease in the 7-day total composite score of abdominal bloating, flatulence, and burping, from baseline to week 8 (7-day recall GITQ)
Measured: 9 weeks
Composite score of 8 GI symptoms (daily GITQ)
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease in the 7-day total composite score of abdominal bloating, flatulence, burping, nausea, vomiting, abdominal cramping, stomach rumbling, and reflux, from baseline to week 8 (daily GITQ)
Measured: 9 weeks
Composite score of 8 GI symptoms (7-day recall GITQ)
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease in the 7-day total composite score of abdominal bloating, flatulence, burping, nausea, vomiting, abdominal cramping, stomach rumbling, and reflux, from baseline to week 8 (7-day recall GITQ)
Measured: 9 weeks
Individual GI symptom scores (daily GITQ)
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease in 7-day individual symptom scores from baseline to week 8, for each of abdominal bloating, flatulence, burping, nausea, vomiting, abdominal cramping, stomach rumbling, and reflux (daily GITQ)
Measured: 9 weeks
Individual GI symptom scores (7-day recall GITQ)
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease in 7-day individual symptom scores from baseline to week 8, for each of abdominal bloating, flatulence, burping, nausea, vomiting, abdominal cramping, stomach rumbling, and reflux (7-day recall GITQ)
Measured: 9 weeks
Composite score of abdominal bloating, flatulence, and burping (interim weeks)
Between placebo and probiotic treatments, the difference in the proportion of participants showing a decrease in the 7-day total composite score of abdominal bloating, flatulence, and burping, from baseline to each measured, interim time point (i.e., week 1, week 2, week 3, week 4, week 5, week 6, week 7) (7-day recall GITQ)
Measured: 2 - 8 weeks
Individual GI symptom scores (interim weeks)
Between placebo and probiotic treatments, the difference in the proportion of participants showing a decrease in the 7-day individual symptom scores for each of abdominal bloating, flatulence, burping, nausea, vomiting, abdominal cramping, stomach rumbling, and reflux, from baseline to each measured, interim time point (i.e., week 1, week 2, week 3, week 4, week 5, week 6, week 7) (7-day recall GITQ)
Measured: 2 - 8 weeks
Small intestinal permeability
Between placebo and probiotic treatments, the difference in small intestinal permeability from baseline to Day 57 (0 to 5 hour urinary lactulose:mannitol ratio)
Measured: 8 weeks
Colonic permeability
Between placebo and probiotic treatments, the difference in colonic permeability from baseline to Day 57 (5 to 24 hour urinary sucralose:erythritol ratio)
Measured: 8 weeks
Gut permeability
Between placebo and probiotic treatments, the difference in gut permeability from baseline to Day 57 (0 to 24 hour urinary sucralose:erythritol ratio)
Measured: 8 weeks
Fecal microbiome profile
Between placebo and probiotic treatments, the difference in "shotgun" metagenomic sequencing-based fecal microbiome profiles from baseline to Day 57
Measured: 8 weeks
Fecal microbiome profile
Between placebo and probiotic treatments, the difference in "shotgun" metagenomic sequencing-based fecal microbiome profiles at end of study
Measured: Day 57
Plasma C-reactive protein
Between placebo and probiotic treatments, change from baseline to week 8 in fasting blood C-reactive protein concentration (mg/L)
Measured: 9 weeks
Serum insulin
Between placebo and probiotic treatments, change from baseline to week 8 in fasting serum insulin concentration (mIU/L)
Measured: 9 weeks
Safety: Albumin
Fasting plasma albumin concentration (g/dL)
Measured: 9 weeks
Safety: Alkaline phosphatase
Fasting plasma alkaline phosphatase concentration (U/L)
Measured: 9 weeks
Safety: Alanine aminotransferase
Fasting plasma alanine aminotransferase concentration (U/L)
Measured: 9 weeks
Safety: Anion gap
Fasting plasma anion gap (nmol/L)
Measured: 9 weeks
Safety: Aspartate aminotransferase
Fasting plasma aspartate aminotransferase concentration (U/L)
Measured: 9 weeks
Safety: Blood urea nitrogen
Fasting blood urea nitrogen concentration (mg/dL)
Measured: 9 weeks
Safety: Osmolality
Fasting plasma osmolality (mOsm/kg)
Measured: 9 weeks
Safety: Calcium
Fasting plasma total calcium concentration (mg/dL)
Measured: 9 weeks
Safety: Chloride
Fasting plasma chloride concentration (mmol/L)
Measured: 9 weeks
Safety: Carbon dioxide
Fasting plasma carbon dioxide concentration (mmol/L)
Measured: 9 weeks
Safety: Creatinine
Fasting plasma creatinine concentration (mg/dL)
Measured: 9 weeks
Safety: Globulin
Fasting plasma globulin concentration (g/dL)
Measured: 9 weeks
Safety: Glucose
Fasting plasma glucose concentration (mg/dL)
Measured: 9 weeks
Safety: Potassium
Fasting plasma potassium concentration (mmol/L)
Measured: 9 weeks
Safety: Sodium
Fasting plasma sodium concentration (mmol/L)
Measured: 9 weeks
Safety: Total bilirubin
Fasting plasma total bilirubin concentration (mg/dL)
Measured: 9 weeks
Safety: Total protein
Fasting plasma total protein concentration (g/dL)
Measured: 9 weeks
Safety: Basophils
Fasting plasma basophil count
Measured: 9 weeks
Safety: Eosinophils
Fasting plasma eosinophil count
Measured: 9 weeks
Safety: Hematocrit
Fasting hematocrit (as volume percent)
Measured: 9 weeks
Safety: Hemoglobin
Fasting plasma hemoglobin concentration (g/dL)
Measured: 9 weeks
Safety: Lymphocytes
Fasting plasma lymphocyte count
Measured: 9 weeks
Safety: Mean corpuscular hemoglobin
Fasting plasma mean corpuscular hemoglobin (pg)
Measured: 9 weeks
Safety: Mean corpuscular hemoglobin concentration
Fasting plasma mean corpuscular hemoglobin concentration (g/dL)
Measured: 9 weeks
Safety: Mean corpuscular volume
Fasting plasma mean corpuscular volume (fL)
Measured: 9 weeks
Safety: Monocytes
Fasting plasma monocyte count
Measured: 9 weeks
Safety: Neutrophils
Fasting plasma neutrophil count
Measured: 9 weeks
Safety: Platelets
Fasting plasma platelet count
Measured: 9 weeks
Safety: Red blood cells
Fasting plasma red blood cell count
Measured: 9 weeks
Safety: White blood cells
Fasting plasma white blood cell count
Measured: 9 weeks
Safety: Blood pressure
Resting systolic blood pressure over resting diastolic blood pressure (mmHg/mmHg)
Measured: 9 weeks
Safety: Heart rate
Resting heart rate (beats per minute)
Measured: 9 weeks
Safety: Incidence of adverse events
Number of participants with self-reported adverse events
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start19 Sep 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIO-CAT Microbials, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Ohio State University
- Responsible party
- Sponsor
- Investigators
- Dawn Beckman, MD, Principal investigator, Biofortis Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595980
- Sponsor's protocol ID
- BIO-2210
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double-blind, Placebo-Controlled Study to Investigate the Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT05595980
- Acronym / sponsor ID
- BIO-2210
- Conditions
- Gastrointestinal Health, Immune Health, Digestive Health
- Keywords
- Bacillus, probiotic, bloating, microbiome, metagenomics, inestinal, permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BIO-CAT Microbials, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Ohio State University
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 27 Oct 2022 (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 primary objective of this study is to investigate the effect of an oral probiotic (Bacillus sp. spore preparation) on abdominal bloating, flatulence, and burping in generally healthy adults. Secondary outcomes include intestinal barrier integrity and fecal microbiome properties (taxonomical structure, diversity, and function).
Detailed description
Probiotics are live microbes that, when administered in adequate amounts, confer a health benefit. Examples of probiotic health benefits include the support of gastrointestinal (GI) health and immune health. Common probiotic strains include species from the Bacillaceae family (e.g. Bacillus genus) and Lactobacillaceae family of the Bacillota phylum (formerly Firmicutes), and species from the Bifidobacterium genus of the Actinomycetota phylum (formerly Actinobacteria). Bacillaceae species are particularly advantageous for oral probiotic applications because they can be manufactured as spores with highly proteinaceous coats that persist without refrigeration and resist the acidic and high bile salt conditions that occur across the human GI tract. The objective of this clinical study is to investigate the effects of daily oral supplementation with a novel Bacillus sp. spore preparation for 8 weeks on GI symptoms, intestinal barrier integrity, and fecal microbiome properties.
This will be a randomized, parallel, double-blind, placebo-controlled study consisting of one screening visit (Visit 1, Day -7) and four study visits (Days 0, 1, 57, and 58). At Visit 1 (Day -7), participants will arrive at the clinic in a fasting state (≥ 10 hours). After participants provide voluntary informed consent, participants will undergo medical history, prior and current medication/supplement use, and inclusion and exclusion criteria assessments. Additionally, height, body weight, and vital signs will be measured, and body mass index (BMI) will be calculated. Blood samples will be collected for chemistry, hematology, C-reactive protein (CRP), and insulin analyses. Participants will be dispensed a daily paper Gastrointestinal Tolerance Questionnaire (GITQ) with instructions to capture events occurring during the seven continuous days prior to Visit 2 (Day 0). The paper GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring during the past 24 hours. Therefore, participants will be instructed to complete their first GITQ on the morning of Day -6 and the final GITQ on the morning of Day 0, just before their Visit 2. Additionally, a stool sample collection kit will be dispensed with instructions to a collect stool sample from a single bowel movement (for fecal microbiome analyses) within the 3 days immediately before Visit 2 (Day 0).
At Visit 2 (Day 0), participants will arrive at the clinic in a fasting state (≥ 10 hours). Participants will undergo clinic visit procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight, and vital signs measurements) and adverse event (AE) assessment. Fecal samples will be collected, and subjects will be administered a 7-day recall GITQ. Participants will then undergo an intestinal permeability test where they will ingest four sugar probes (1 g mannitol, 1 g sucralose, 1 g erythritol, and 5 g lactulose) in approximately 240 mL water. Participants will be dispensed 2 separate containers to collect all urine over the following 24 hours, with urine collected from 0 to 5 hours in one container and from 5 to 24 hours in the second container. Participants will be instructed to return both containers to the clinic the following day at Visit 3 (Day 1). Upon completion of the GI permeability test, participants will be randomly assigned to a study product sequence. Participants will receive an email link for an electronic 7-day recall GITQ to be completed on Days 8, 15, 22, 29, 36, 43, 50, and 57. Participants will also receive information regarding daily links that will be sent via email to complete electronic 24-hour recall GITQs and will be instructed to complete these electronic 24-hour GITQs daily starting on day 51, which will be 6 days ahead of Visit 4. Participants will continue recording the 24-hour GITQ recall every day for seven total days (Days 51, 52, 53, 54, 55, 56, and 57). Additionally, a stool sample collection kit will be dispensed with instructions to collect a stool sample from a single bowel movement for fecal microbiome analyses within the 3 days immediately before Visit 4 (Day 57). In addition, a subset of male subjects will be selected to collect an additional fecal sample for fecal metabolomic and/or targeted analyte analyses.
At Visit 3 (Day 1), participants will return the 24-hour urine sample collection containers and undergo AE assessments. Participants will be dispensed their assigned study product and will be instructed to consume it once a day (1 capsule/d) with their meal that is typically the largest of the day for 56 days starting on Day 1.
At Visit 4 (Day 57), participants will arrive at the clinic fasted (≥ 10 hours) and undergo clinic visit procedures, including: concomitant medication/supplement use, review inclusion/exclusion criteria, body weight and vital signs measurements, and AE assessment. Fecal samples will be collected. Blood samples will be collected for chemistry, hematology, CRP, and insulin analyses. Participants will then complete the intestinal permeability test with the same procedures and study instructions described at Visit 2.
At Visit 5 (Day 58), participants will return the 24-hour urine sample collection containers and undergo AE assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticBacillus strain spore preparation |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo maltodextrin |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, 30-65 years of age, inclusive at Visit 1 (Day -7)
- BMI of 18.50 to 31.99 kg/m^2, inclusive, at Visit 1 (Day -7)
- Have ≥ 3 weekly total symptom score obtained by combining ratings for gas/flatulence, abdominal bloating, and burping symptoms (e.g., 3 days with a mild severity across the three symptoms, 1 day of mild severity and 1 day of moderate severity across the three symptoms, or 1 day of severe severity across the three symptoms)
- Consumes a typical American diet (defined as ≤ 3 servings/d of fruits and vegetables combined and < 3 servings/d of whole grains)
- Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period
Key exclusion criteria (28 listed)
- Known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Abnormal laboratory test results of clinical significance at Visit 1 (Day -7), at the discretion of the Clinical Investigator
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies)
- Pre-menopausal female subject with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to Visit 1)
- Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥ 3 loose or liquid stools/d)
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 |
|---|---|---|
| ProbioticParticipants will consume 1 capsule containing 2 billion CFU of a Bacillus strain spore preparation once daily for 56 days | Dietary supplement | Probiotic |
| PlaceboParticipants will consume 1 capsule containing maltodextrin once daily for 56 days | Dietary supplement | Placebo |
Primary outcome
Composite score of abdominal bloating, flatulence, and burping (daily GITQ)
Time frame: 9 weeks
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease (indicating improvement) in the 7-day total composite score of abdominal bloating, flatulence, and burping, from baseline to week 8, where an increase in scores (indicating worsening) cannot occur within any of the 3 symptoms (daily Gastrointestinal Tolerance Questionnaire [GITQ])
47 secondary outcomes
Composite score of abdominal bloating, flatulence, and burping (7-day recall GITQ)
Time frame: 9 weeks
Composite score of 8 GI symptoms (daily GITQ)
Time frame: 9 weeks
Composite score of 8 GI symptoms (7-day recall GITQ)
Time frame: 9 weeks
Individual GI symptom scores (daily GITQ)
Time frame: 9 weeks
Individual GI symptom scores (7-day recall GITQ)
Time frame: 9 weeks
Composite score of abdominal bloating, flatulence, and burping (interim weeks)
Time frame: 2 - 8 weeks
Individual GI symptom scores (interim weeks)
Time frame: 2 - 8 weeks
Small intestinal permeability
Time frame: 8 weeks
Colonic permeability
Time frame: 8 weeks
Gut permeability
Time frame: 8 weeks
Fecal microbiome profile
Time frame: 8 weeks
Fecal microbiome profile
Time frame: Day 57
Plasma C-reactive protein
Time frame: 9 weeks
Serum insulin
Time frame: 9 weeks
Safety: Albumin
Time frame: 9 weeks
Safety: Alkaline phosphatase
Time frame: 9 weeks
Safety: Alanine aminotransferase
Time frame: 9 weeks
Safety: Anion gap
Time frame: 9 weeks
Safety: Aspartate aminotransferase
Time frame: 9 weeks
Safety: Blood urea nitrogen
Time frame: 9 weeks
Safety: Osmolality
Time frame: 9 weeks
Safety: Calcium
Time frame: 9 weeks
Safety: Chloride
Time frame: 9 weeks
Safety: Carbon dioxide
Time frame: 9 weeks
Safety: Creatinine
Time frame: 9 weeks
Safety: Globulin
Time frame: 9 weeks
Safety: Glucose
Time frame: 9 weeks
Safety: Potassium
Time frame: 9 weeks
Safety: Sodium
Time frame: 9 weeks
Safety: Total bilirubin
Time frame: 9 weeks
Safety: Total protein
Time frame: 9 weeks
Safety: Basophils
Time frame: 9 weeks
Safety: Eosinophils
Time frame: 9 weeks
Safety: Hematocrit
Time frame: 9 weeks
Safety: Hemoglobin
Time frame: 9 weeks
Safety: Lymphocytes
Time frame: 9 weeks
Safety: Mean corpuscular hemoglobin
Time frame: 9 weeks
Safety: Mean corpuscular hemoglobin concentration
Time frame: 9 weeks
Safety: Mean corpuscular volume
Time frame: 9 weeks
Safety: Monocytes
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Dawn Beckman, MD principal investigator
Biofortis Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Gastrointestinal Health and Immune Health, run by BIO-CAT Microbials, LLC 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 11 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: finished, as of the sponsor's last update on 6 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite score of abdominal bloating, flatulence, and burping (daily GITQ) (time frame: 9 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 6 Feb 2023.