The rationale for the current study is to initially evaluate the safety and tolerability of B. longum strain in healthy volunteers.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
36
The study product is probiotic
CTC, Dag Hammarskjölds väg 10B
Uppsala, Sweden
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.
Time frame: 28 Days
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.
Time frame: 28 Days
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