Healthy VolunteersNCT04692506
Study Evaluating the Safety and Tolerability
A study testing Probiotic in people with Healthy Volunteers, run by BioGaia AB at 1 site in Sweden.
Trial summary
The rationale for the current study is to initially evaluate the safety and tolerability of B. longum strain 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
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- 5 Jan 2021to 24 Feb 2021
- 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.
- Women of child bearing potential (WOCBP) 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 (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.
- Women 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 any clinically significant disease or disorder which, 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 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 Bifidobacterium probiotic treatment.
Show all 19Show 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.
- Lactose intolerance (that in the opinion of the Investigator would interfere with the use of yoghurt drinks once daily for 28 days).
- 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 two weeks prior to the first administration of IP.
- Planned treatment or treatment with an investigational drug within 3 months prior to Day 1. Subjects consented and screened but not dosed in previous phase I studies are not excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP.
- 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
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Safety and Tolerability of Bifidobacterium Longum DSM 32947 Administered to Healthy Volunteers for 28 Days.
The rationale for the current study is to initially evaluate the safety and tolerability of B. longum strain in healthy volunteers.
Read the detailed description
The design of the study is based on the aim to study safety and tolerability of B. longum in a limited number of healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
The study product is probiotic
| Study group | Role | What they receive |
|---|---|---|
| Low dose: Sachet with B. longum | Active comparator | The IP will be self-administered by the subject. Subjects will be asked to consume the IP (1 sachet) once per day, at approximately the same time every day, for 28 days.
The sachet should be emptied in, and mixed with, a bottle of milk. Receives: Other: Probiotic |
| High dose: Sachet with B. longum | Active comparator | The IP will be self-administered by the subject. Subjects will be asked to consume the IP (1 sachet) once per day, at approximately the same time every day, for 28 days.
The sachet should be emptied in, and mixed with, a bottle of milk. Receives: Other: Probiotic |
| Placebo Sachet | Placebo comparator | The IP will be self-administered by the subject. Subjects will be asked to consume the IP (1 sachet) once per day, at approximately the same time every day, for 28 days.
The sachet should be emptied in, and mixed with, a bottle of milk. Receives: Other: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of treatment emergent adverse events ( safety and tolerability) of B. longum administered to healthy subjects for 28 days.
The product to be investigated is a probiotic not an investigational medicinal. 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 in supine position after 10 minutes of rest. 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 analysis will be performed using dip sticks. Urine pregnancy tests 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/symptom should be reported as the AE.
Measured: 28 Days
Secondary outcomes (1)
To evaluate tolerability in terms of gastrointestinal (GI) symptoms during 28 days
To evaluate gastrointestinal symptoms by using Gastrointestinal Symptom Rating Scale( GSRS) over the last week. The questionnaire will be answered by the subjects at Visits 2 to 5 The GSRS is a disease-specific instrument. The 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The reliability and validity of the GSRS are well-documented, and norm values for a general population are available.
The data collected using the GSRS does not constitute AEs and will not be reported as such but will be reported as numerical results. Accordingly, no causality assessment by the Investigator will be performed for the GSRS 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 posted31 Dec 2020
- Study start5 Jan 2021
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
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
- Adouble-blind, randomised, placebo-controlled, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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 Hammarskjölds väg 10B SE-752 37 Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692506
- Sponsor's protocol ID
- CSUB0186
- Status last verified
- Jun 2021
- First submitted
- 16 Dec 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jun 2021. 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 Bifidobacterium Longum DSM 32947 Administered to Healthy Volunteers for 28 Days.
- ClinicalTrials.gov ID
- NCT04692506
- Acronym / sponsor ID
- CSUB0186
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 31 Dec 2020 (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 B. longum strain in healthy volunteers.
Detailed description
The design of the study is based on the aim to study safety and tolerability of B. longum 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
- Adouble-blind, randomised, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Low dose: Sachet with B. longum | Active comparator | Other: ProbioticThe IP will be self-administered by the subject. Subjects will be asked to consume the IP (1 sachet) once per day, at approximately the same time every day, for 28 days. The sachet should be emptied in, and mixed with, a bottle of milk. |
| High dose: Sachet with B. longum | Active comparator | Other: ProbioticThe IP will be self-administered by the subject. Subjects will be asked to consume the IP (1 sachet) once per day, at approximately the same time every day, for 28 days. The sachet should be emptied in, and mixed with, a bottle of milk. |
| Placebo Sachet | Placebo comparator | Other: ProbioticThe IP will be self-administered by the subject. Subjects will be asked to consume the IP (1 sachet) once per day, at approximately the same time every day, for 28 days. The sachet should be emptied in, and mixed with, a bottle of milk. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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.
- Women of child bearing potential (WOCBP) 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 (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.
Key exclusion criteria (19 listed)
- History of any clinically significant disease or disorder which, 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 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 probiotic | Other | High dose: Sachet with B. longum, Low dose: Sachet with B. longum, Placebo Sachet |
Primary outcome
To evaluate the incidence of treatment emergent adverse events ( safety and tolerability) of B. longum administered to healthy subjects for 28 days.
Time frame: 28 Days
The product to be investigated is a probiotic not an investigational medicinal. 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 in supine position after 10 minutes of rest. 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 analysis will be performed using dip sticks. Urine pregnancy tests 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/symptom should be reported as the AE.
1 secondary outcome
To evaluate tolerability in terms of gastrointestinal (GI) symptoms during 28 days
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 18 Jun 2021.
- 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.
Erik Rein-Hedin, MD principal investigator
CTC Clinical Trial Consultants AB Dag Hammarskjölds väg 10B SE-752 37 Uppsala, Sweden
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 Healthy Volunteers, run by BioGaia AB at 1 site 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 6 inclusion and 19 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 18 Jun 2021. 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 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 emergent adverse events ( safety and tolerability) of B. longum administered to healthy subjects for 28 days. (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 18 Jun 2021.