Body Weight Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Intervention Study to Assess the Safety and Tolerance Effect of Three Probiotic Strains in Infants
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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