Healthy VolunteersNCT05044949
Study Evaluating the Safety and Tolerability of a Probioitc
A study testing Probiotic in people with Healthy Volunteers and Tolerability, run by BioGaia AB at 2 sites in Sweden.
Trial summary
The rationale for the current study is to initially evaluate the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Tolerability, Safety
- 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
- 35 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Nov 2021to 20 Jan 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Healthy male or female subject aged 18-65 years inclusive.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
- Clinically normal medical history, physical findings, vital signs, and laboratory values at the time of screening, as judged by the Investigator.
- Female subjects of child bearing potential must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory).
Who cannot join
- History of or ongoing clinically significant disease that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibodies or HIV.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to Lactobacillus probiotic treatment.
Show all 20Show fewer
- History of, or ongoing GI disorder, including but not limited to irritable bowel syndrome (IBS), constipation, loose stools or excess gas which, in the discretion of the Investigator, may influence the results or the subject's ability to participate in the study.
- Regular use of any prescribed or non-prescribed medication including antacids and analgesics within 2 weeks prior to the first administration of IP, at the discretion of the Investigator.
- Any use of antibiotics (except local treatment, e.g., eye drops) within 2 weeks prior to the first administration of IP.
- Regular use of supplements, i.e., tablets, drops, capsules etc, that contain L. reuteri or any other probiotics within 2 weeks prior to the first administration of IP.
- Regular intake of foods or beverages that contain L. reuteri or any other probiotics, e.g., yoghurt and other probiotic dairy products, within 2 weeks prior to the first administration of IP. Foods that contain microorganisms, live or dead, that do not confer any health benefit on the host, e.g., regular yoghurt, are allowed.
- Planned treatment or treatment with an investigational drug within 3 months prior to Day 1. Subjects consented and screened but not dosed in previous clinical studies are not excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before the screening visit.
- Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP. Drugs of abuse and alcohol will also be screened during the study (refer to Section 9.6.1).
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of, anabolic steroids, as judged by the Investigator.
- Excessive caffeine consumption defined by a daily intake of > 5 cups of caffeine-containing beverages.
- Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Clinical Trial Consultants AB
Uppsala, 752 37
CTC, Dag Hammarskjölds väg 10B
Uppsala, 75237
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Safety and Tolerability of Limosilactobacillus Reuteri Administered to Healthy Volunteers.
The rationale for the current study is to initially evaluate the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers.
Read the detailed description
Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host. Probiotics have been studied for decades for their potential health benefits of non-pathogenic microorganisms. The species Limosilactobacillus reuteri (L. reuteri), formerly Lactobacillus reuteri, is currently used in probiotic products.
The design of the study is based on the aim to study the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in a limited number of healthy volunteers.
- Conditions
- Healthy Volunteers, Tolerability, Safety
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
The study product is a probiotic strain
PlaceboOther
The study product is a placebo to the probiotic strain
| Study group | Role | What they receive |
|---|---|---|
| Low dose L reuteri capsules | Active comparator | Subjects will be asked to consume 2 capsules with high dose L reuteri per day in 28 days. Receives: Other: Probiotic |
| High dose L reuteri capsules | Active comparator | Subjects will be asked to consume 2 capsules with a low dose L reuteri per day in 28 days. Receives: Other: Probiotic |
| Placebo capsules | Placebo comparator | Subjects will be asked to consume 2 capsules with placebo powder per day in 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of treatment emergency adverse events (safety and tolerability).
The product to be investigated is a probiotic product and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product.
Vital signs, systolic and diastolic blood pressure and pulse will be measured. Vital signs will be judged as normal, abnormal, not clinically significant or abnormal, clinically significant.
Safety laboratory parameters, blood samples for analysis of clinical chemistry and haematology will be analysed by routine analytical methods.
Urine drug screen and urine pregnancy test will be performed. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs. If an abnormal value is associated with corresponding clinical signs or symptoms, the sign/symptoms should be reported as the AE.
Measured: 28 days
Secondary outcomes (1)
To evaluate tolerability in terms of gastrointestinal symptoms
To evaluate gastrointestinal symptoms by using Gastrointestinal Symptom Rating Scale (GSRS) over the last week. The questionnaire will be answered by the subjects at visit 2 to 5.
The Gastrointestinal Symptom Rating Scale is a disease-specific instrument. The 15 items are combined into five clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The subjects are asked to numerically score their subjective symptoms 1-7. Thus the lowest score is 15 and the highest is105. The higher score the worse outcome. The reliability and validity of the Gastrointestinal Symptom Rating Scale are well-documented, and norm values for a general population are available.
The data collected using the Gastrointestinal Symptom Rating Scale does not constitute AEs and will not be reported as numerical results. Accordingly, no causality assessment by the Investigator will be performed for the Gastrointestinal Symptom Rating Scale questionnaire.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomised, placebo-controlled, parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Rein-Hedin, MD, Principal investigator, CTC Clinical Trial Consultants AB,Dag Hammarskjolds v- 10B, SE-752 37 Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044949
- Sponsor's protocol ID
- CSUB0196
- Status last verified
- Jan 2022
- First submitted
- 2 Sep 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Safety and Tolerability of Limosilactobacillus Reuteri Administered to Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05044949
- Acronym / sponsor ID
- CSUB0196
- Conditions
- Healthy Volunteers, Tolerability, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 16 Sep 2021 (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 the current study is to initially evaluate the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers.
Detailed description
Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host. Probiotics have been studied for decades for their potential health benefits of non-pathogenic microorganisms. The species Limosilactobacillus reuteri (L. reuteri), formerly Lactobacillus reuteri, is currently used in probiotic products.
The design of the study is based on the aim to study the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in a limited number of healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomised, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Low dose L reuteri capsules | Active comparator | Other: ProbioticSubjects will be asked to consume 2 capsules with high dose L reuteri per day in 28 days. |
| High dose L reuteri capsules | Active comparator | Other: ProbioticSubjects will be asked to consume 2 capsules with a low dose L reuteri per day in 28 days. |
| Placebo capsules | Placebo comparator | Other: PlaceboSubjects will be asked to consume 2 capsules with placebo powder per day in 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent for participation in the study.
- Healthy male or female subject aged 18-65 years inclusive.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
- Clinically normal medical history, physical findings, vital signs, and laboratory values at the time of screening, as judged by the Investigator.
- Female subjects of child bearing potential must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory).
Key exclusion criteria (20 listed)
- History of or ongoing clinically significant disease that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibodies or HIV.
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 |
|---|---|---|
| ProbioticThe study product is a probiotic strain | Other | High dose L reuteri capsules, Low dose L reuteri capsules |
| PlaceboThe study product is a placebo to the probiotic strain | Other | Placebo capsules |
Primary outcome
To evaluate the incidence of treatment emergency adverse events (safety and tolerability).
Time frame: 28 days
The product to be investigated is a probiotic product and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product. Vital signs, systolic and diastolic blood pressure and pulse will be measured. Vital signs will be judged as normal, abnormal, not clinically significant or abnormal, clinically significant. Safety laboratory parameters, blood samples for analysis of clinical chemistry and haematology will be analysed by routine analytical methods. Urine drug screen and urine pregnancy test will be performed. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs. If an abnormal value is associated with corresponding clinical signs or symptoms, the sign/symptoms should be reported as the AE.
1 secondary outcome
To evaluate tolerability in terms of gastrointestinal symptoms
Time frame: 28 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 11 Feb 2022.
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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.
Erik Rein-Hedin, MD principal investigator
CTC Clinical Trial Consultants AB,Dag Hammarskjolds v- 10B, SE-752 37 Uppsala, Sweden
2 sites 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 Healthy Volunteers and Tolerability, run by BioGaia AB at 2 sites in Sweden.
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 5 inclusion and 20 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
To evaluate the incidence of treatment emergency adverse events (safety and tolerability). (time frame: 28 days). 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 11 Feb 2022.