Safety and Tolerance Study of Three Probiotic Strains in Infants
Condition: Body Weight; Body Height; Head Circumference
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy
      infants. Participants are divided at random and unknown to the researchers, in four groups,
      three of which receive one of three probiotic bacteria while the fourth group receives
      placebo product.
    

Detailed description: 
      Subjects' parents or legal tutors will be contacted for voluntary participation and a written
      informed consent will be obtained.

      The study visits will take place either in the hospital or primary health center.

      During Visit 1, inclusion in- and exclusion criteria will be checked and information on
      demographic profile, subject characteristics, feeding option, relevant medical history,
      medication and nutritional supplements will be recorded. Weight and length and head
      circumference measurements of the infant will be made. The researcher will explain to the
      parents that during the first 2 weeks of participation in the study the infant must not
      intake any probiotic supplements (run-in ). Parents will be instructed to collect and send
      and/or store fecal and urine samples before starting the study. In addition they will be
      instructed to collect and send and/or store fecal and urine samples after the initial run-in
      period (2 weeks), after the product intake period (8 weeks) and after the final wash out
      period (2 weeks).

      During Visit 2, subjects will be randomly allocated to receive either one of the test
      products or the placebo. Body weight and length will be measure. The researcher will review
      with the parents the study diary in detail, how to record data on gastrointestinal tolerance,
      stool frequency and stool characteristics, respiratory symptoms, diagnosed infections,
      sleeping and crying habits, changes in sleeping pattern, fever episodes, unscheduled visits
      resulting from suspected infection or a health problem and antibiotic prescription. The
      researcher will explain the procedure of administering the study product to the infant and
      anticipated phone calls. The parents will be instructed to start intake of the product as
      soon as possible after the collection of fecal and urine samples.

      During product intake period (8 weeks) subject's parents will be called weekly by someone
      from the Study Team (Phone call 1, 2, 3, 4, 5, 6, 7). During the phone call relevant data
      related to possible Adverse Events (AEs) or Serious Adverse Events (SAEs) will be collected.
      Parents will be asked about infant's well-being (fever episodes, rashes, diarrhea, visits to
      the doctor, antibiotic prescription, etc.). Issues regarding diary completion, if any, will
      be discussed. During the Phone call 7 parents will be instructed to collect and send and/or
      store fecal and urine samples in one of the days prior to the third visit.

      At the third visit (Visit 3, 8 weeks after product intake period), body weight and length
      will be measured and relevant data will be collected with respect to health and well-being
      aspect of the infant and AE or SAE (fever episodes, rashes, diarrhea, visits to the doctor,
      antibiotic prescription, etc.). Completed diaries and fecal and urine samples will be
      collected. Parents will be explained that for the last 2 weeks of participation in the study
      their infants could not intake any probiotic supplement (final wash out period). Parents will
      be instructed to collect and send and/or store fecal and urine samples in one of the days
      prior to the next visit (Visit 4).

      During visit 4, after the final wash out period, body weight and length will be measured and
      relevant data will be collected with respect to health and well-being aspect of the infant
      and AEs or SAEs (fever episodes, rashes, diarrhea, visits to the doctor, antibiotic
      prescription, etc.). Completed diaries and samples will be collected.
    

Intervention name(s): Bifidobacterium longum ssp infantis R0033; Lactobacillus helveticus R0052; Bifidobacterium bifidum R0071; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU); 12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU); 12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU); 12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Dietary supplementation; Probiotics; Safety/Efficiency; Healthy infants