Healthy AdultsNCT04044144
Prospective Tolerability Assessment of a Probiotic Dietary Supplement
A study testing Probiotic Dietary Supplement in people with Healthy Adults, run by Metagenics, Inc. at 1 site in United States.
Trial summary
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Probiotic Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to 23 Aug 2019
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-75 years
Who cannot join
- Currently taking a probiotic, prebiotic, or fiber supplement (or they were taken within 10 days prior to screening)
- Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within 28 days prior to screening)
- Currently taking any supplements or medications impacting gastrointestinal motility
- Active gastrointestinal infection
- Current or previous history of chronic bowel disease
- Current or previous history of liver disease
Show all 22Show fewer
- Current or previous history of chronic kidney disease
- History of gastrointestinal surgery
- A major medical or surgical event requiring hospitalization within 3 months prior to screening
- Current or previous history of cardiovascular disease
- Current or previous history of pre-Diabetes, diabetes mellitus, or hypoglycemia
- Known infection with human immunodeficiency virus, tuberculosis, hepatitis B or hepatitis C
- Genitourinary bacterial infections within 28 days prior to screening
- Current or previous history of seizure disorder
- Current or previous history of psychiatric illness
- History of alcoholism
- Cancer within the last 5 years
- Smoking or use of nicotine containing products within 28 days prior to screening
- Use of drugs of abuse and recreational drugs/substances within 12 months prior to screening
- Known intolerance or allergy to ingredients in the study supplement
- Women who are lactating, pregnant or planning pregnancy within the next two months
- Currently participating in another interventional research study or participated in another interventional study within 28 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Personalized Lifestyle Medicine Center
Gig Harbor, Washington, 98332
About this study
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. This prospective study will evaluate the tolerability of the eight strain formula in healthy adults.
Read the detailed description
Background \& Significance:
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects.
Research Design \& Methods:
This prospective study will evaluate the tolerability of the eight strain formula in healthy adults over a 10-day period. The primary aim of the study is to assess tolerability as determined by the frequency of study participants who withdraw from the study due to adverse events.
- Conditions
- Healthy Adults
- Being tested
- Probiotic Dietary Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Dietary SupplementDietary supplement
Dietary supplement containing a combination of 8 probiotic strains
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Dietary Supplement | Experimental | Subjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days Receives: Dietary Supplement: Probiotic Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of participants who withdraw from the study due to adverse events during the supplementation period
Tolerability of oral intake of the probiotic supplement will primarily be evaluated by determining the frequency of participants who withdraw from the study due to adverse events during the supplementation period
Measured: 0-10 days
Secondary outcomes (37)
White blood cell count
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Red blood cell count
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Hemoglobin
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Hematocrit
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Mean corpuscular volume
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Mean corpuscular hemoglobin
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Mean corpuscular hemoglobin conc.
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Red cell distribution width
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Platelet count
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Mean platelet volume
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Absolute Neutrophils
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Absolute Lymphocytes
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Absolute Monocytes
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Absolute Eosinophils
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Absolute Basophils
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Neutrophils
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Lymphocytes
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Monocytes
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Eosinophils
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Basophils
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Albumin
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Globulin
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Albumin/Globulin Ratio
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Alkaline Phosphatase
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Alanine Transaminase
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Aspartate Aminotransferase
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Blood urea nitrogen (BUN)
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Creatinine
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
BUN/Creatinine ratio
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Calcium
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Carbon Dioxide
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Chloride
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Estimated Glomerular Filtration Rate
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Potassium
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Sodium
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Bilirubin
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Total Protein
Frequency of adverse change before and after the supplementation period
Measured: 0-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start12 Aug 2019
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
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 Healthy AdultsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University of Natural Medicine
- Responsible party
- Sponsor
- Investigators
- Noelle Patno, PhD, Principal investigator, Metagenics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044144
- Sponsor's protocol ID
- 2019-015
- Status last verified
- Apr 2022
- First submitted
- 1 Aug 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryan JJ, Patno NM. Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults. Integr Med (Encinitas). 2021 Feb;20(1):24-34.
PubMed 34393673
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Tolerability Assessment of a Probiotic Dietary Supplement
- ClinicalTrials.gov ID
- NCT04044144
- Acronym / sponsor ID
- 2019-015
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National University of Natural Medicine
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 5 Aug 2019 (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 dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. This prospective study will evaluate the tolerability of the eight strain formula in healthy adults.
Detailed description
Background \& Significance:
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects.
Research Design \& Methods:
This prospective study will evaluate the tolerability of the eight strain formula in healthy adults over a 10-day period. The primary aim of the study is to assess tolerability as determined by the frequency of study participants who withdraw from the study due to adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Probiotic Dietary Supplement | Experimental | Dietary Supplement: Probiotic Dietary SupplementSubjects will be asked to take 1 capsule per day of the dietary supplement for a period of 10 days |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 21-75 years
Key exclusion criteria (22 listed)
- Currently taking a probiotic, prebiotic, or fiber supplement (or they were taken within 10 days prior to screening)
- Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within 28 days prior to screening)
- Currently taking any supplements or medications impacting gastrointestinal motility
- Active gastrointestinal infection
- Current or previous history of chronic bowel disease
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 |
|---|---|---|
| Probiotic Dietary SupplementDietary supplement containing a combination of 8 probiotic strains | Dietary supplement | Probiotic Dietary Supplement |
Primary outcome
Frequency of participants who withdraw from the study due to adverse events during the supplementation period
Time frame: 0-10 days
Tolerability of oral intake of the probiotic supplement will primarily be evaluated by determining the frequency of participants who withdraw from the study due to adverse events during the supplementation period
37 secondary outcomes
White blood cell count
Time frame: 0-10 days
Red blood cell count
Time frame: 0-10 days
Hemoglobin
Time frame: 0-10 days
Hematocrit
Time frame: 0-10 days
Mean corpuscular volume
Time frame: 0-10 days
Mean corpuscular hemoglobin
Time frame: 0-10 days
Mean corpuscular hemoglobin conc.
Time frame: 0-10 days
Red cell distribution width
Time frame: 0-10 days
Platelet count
Time frame: 0-10 days
Mean platelet volume
Time frame: 0-10 days
Absolute Neutrophils
Time frame: 0-10 days
Absolute Lymphocytes
Time frame: 0-10 days
Absolute Monocytes
Time frame: 0-10 days
Absolute Eosinophils
Time frame: 0-10 days
Absolute Basophils
Time frame: 0-10 days
Neutrophils
Time frame: 0-10 days
Lymphocytes
Time frame: 0-10 days
Monocytes
Time frame: 0-10 days
Eosinophils
Time frame: 0-10 days
Basophils
Time frame: 0-10 days
Albumin
Time frame: 0-10 days
Globulin
Time frame: 0-10 days
Albumin/Globulin Ratio
Time frame: 0-10 days
Alkaline Phosphatase
Time frame: 0-10 days
Alanine Transaminase
Time frame: 0-10 days
Aspartate Aminotransferase
Time frame: 0-10 days
Blood urea nitrogen (BUN)
Time frame: 0-10 days
Creatinine
Time frame: 0-10 days
BUN/Creatinine ratio
Time frame: 0-10 days
Calcium
Time frame: 0-10 days
Carbon Dioxide
Time frame: 0-10 days
Chloride
Time frame: 0-10 days
Estimated Glomerular Filtration Rate
Time frame: 0-10 days
Potassium
Time frame: 0-10 days
Sodium
Time frame: 0-10 days
Bilirubin
Time frame: 0-10 days
Total Protein
Time frame: 0-10 days
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 Apr 2022.
- Results publication: PubMed 34393673Ryan JJ, Patno NM. Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults. Integr Med (Encinitas). 2021 Feb;20(1):24-34.
- Full TextLink provided by the sponsor.
- 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.
Noelle Patno, PhD principal investigator
Metagenics, 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 Dietary Supplement in people with Healthy Adults, run by Metagenics, Inc. 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 1 inclusion and 22 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 Apr 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. 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?
Frequency of participants who withdraw from the study due to adverse events during the supplementation period (time frame: 0-10 days). 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 NCT04044144, 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 6 Apr 2022.