MicrobiotaNCT05614726
A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study
A study testing 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase in people with Microbiota and Constipation, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial summary
This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Constipation, Candida
- What is being tested?
- 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 17 Mar 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all participants were required to be between 30-60yr
- score ≥12 on the GSRS
- have a body mass ≥120 pounds (54.5kg)
- body mass index (BMI) between 20.0-34.99kg/m2
- normotensive (<140/<90mmHg)
- normal resting heart rate (<90bpm)
Who cannot join
- Female participants who were pregnant or nursing
- history of unstable or new-onset cardiovascular or cardiorespiratory disease;
- stroke, diabetes, or other endocrine disorder;
- use of any nutritional supplement known to alter the gut microbiota/microflora;
- use of probiotic supplements or prebiotic supplements in the previous 4 weeks and for the duration of the study;
- use of any antibiotics, antifungals, antivirals, or antiparasitic within 8 weeks of the start of the study or throughout the study;
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- any changes in diet within 4 weeks of study start date or throughout study duration;
- if the participant was unwilling to abstain from gut altering supplements for the study;
- malignancy in the previous 5yr except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin);
- prior gastrointestinal bypass surgery (i.e., Lapband);
- any known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism [e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU)];
- any chronic inflammatory condition/disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.);
- known sensitivity to any ingredient in the test formulations as listed in the certificates of analysis.
- currently participating in another research study with an investigational product or had participated in another research study in the past 30 days
- any other diseases/conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences).
Subjects will attend three study visits. During Visit 1, subjects will be screened for participation [i.e., medical history, routine blood work, background baseline diet]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.
- Conditions
- Microbiota, Constipation, Candida
- Being tested
- 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase
- Medical subject headings
- Constipation, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylaseDietary supplement
A multi-strain probiotic blend
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Consists of 575 mg rice oligodextrin Receives: Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase |
| Active | Active comparator | Consists of 575mg [30 billion colony forming units probiotic blend of Bifidobacterium breve 19bx, Lactobacillus acidophilus 16axg, Lacticaseibacillus rhamnosus 18fx, Saccharomyces boulardii 16mxg, and alpha amylase Receives: Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flatulence (gas)
Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.
Measured: Change from baseline to 6 weeks.
Gastro-intestinal bloating
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
Measured: Change from baseline to 6 weeks.
Abdominal discomfort
Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort.
Measured: Change from baseline to 6 weeks.
Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems.
Measured: Change from baseline to 6 weeks.
Secondary outcomes (3)
Stool consistency
Stool consistency as measured by a 10 cm visual analogue scale, where higher values represent harder stools.
Measured: Change from baseline to 6 weeks.
Stool regularity
Stool regularity as measured by a 10 cm visual analogue scale, where higher values represent more regular stools.
Measured: Change from baseline to 6 weeks.
Constipation
Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation.
Measured: Change from baseline to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start18 Jun 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biohm Health, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614726
- Sponsor's protocol ID
- 21-CAHS-102
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
La Monica MB, Raub B, Lopez HL, Ziegenfuss TN. A probiotic amylase blend reduces gastrointestinal symptoms in a randomised clinical study. Benef Microbes. 2023 Oct 23;14(5):459-476. doi: 10.1163/18762891-20230043.
PubMed 38350481
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
- ClinicalTrials.gov ID
- NCT05614726
- Acronym / sponsor ID
- 21-CAHS-102
- Conditions
- Microbiota, Constipation, Candida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biohm Health, LLC
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 14 Nov 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.
This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences).
Subjects will attend three study visits. During Visit 1, subjects will be screened for participation [i.e., medical history, routine blood work, background baseline diet]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylaseConsists of 575 mg rice oligodextrin |
| Active | Active comparator | Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylaseConsists of 575mg [30 billion colony forming units probiotic blend of Bifidobacterium breve 19bx, Lactobacillus acidophilus 16axg, Lacticaseibacillus rhamnosus 18fx, Saccharomyces boulardii 16mxg, and alpha amylase |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- all participants were required to be between 30-60yr
- score ≥12 on the GSRS
- have a body mass ≥120 pounds (54.5kg)
- body mass index (BMI) between 20.0-34.99kg/m2
- normotensive (<140/<90mmHg)
Key exclusion criteria (15 listed)
- Female participants who were pregnant or nursing
- history of unstable or new-onset cardiovascular or cardiorespiratory disease;
- stroke, diabetes, or other endocrine disorder;
- use of any nutritional supplement known to alter the gut microbiota/microflora;
- use of probiotic supplements or prebiotic supplements in the previous 4 weeks and for the duration of the study;
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 |
|---|---|---|
| 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylaseA multi-strain probiotic blend | Dietary supplement | Active, Placebo |
Primary outcome
Flatulence (gas)
Time frame: Change from baseline to 6 weeks.
Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.
Gastro-intestinal bloating
Time frame: Change from baseline to 6 weeks.
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
Abdominal discomfort
Time frame: Change from baseline to 6 weeks.
Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort.
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Change from baseline to 6 weeks.
Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems.
3 secondary outcomes
Stool consistency
Time frame: Change from baseline to 6 weeks.
Stool regularity
Time frame: Change from baseline to 6 weeks.
Constipation
Time frame: Change from baseline to 6 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 14 Nov 2022.
- Derived from this study: PubMed 38350481La Monica MB, Raub B, Lopez HL, Ziegenfuss TN. A probiotic amylase blend reduces gastrointestinal symptoms in a randomised clinical study. Benef Microbes. 2023 Oct 23;14(5):459-476. doi: 10.1163/18762891-20230043.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase in people with Microbiota and Constipation, run by The Center for Applied Health Sciences, 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 6 inclusion and 15 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 14 Nov 2022. 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?
Flatulence (gas) (time frame: Change from baseline to 6 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05614726, which also lists 1 linked publication.
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 14 Nov 2022.