Clinical trial NCT02215304: Safety and Tolerance Study of Three Probiotic Strains in Infants
Official title: A Randomized, Double-blind, Placebo-controlled Intervention Study to Assess the Safety and Tolerance Effect of Three Probiotic Strains in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Body Height
Head Circumference
Keywords: Dietary supplementation
Probiotics
Safety/Efficiency
Healthy infants
Lead sponsor: ProbiSearch SL
Sponsor class: INDUSTRY
Collaborators: name: Lallemand Health Solutions
First posted: 2014-08-13
Enrollment: 221
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy term infants between 3-12 months old
* Written informed consent from at least one parent or the legal tutor.

Exclusion Criteria:

* Short bowel syndrome or any GI surgery.
* Impaired intestinal epithelial barrier (e.g. diarrheal illness, intestinal inflammation).
* Metabolic disorders (diabetes, lactose intolerance).
* Immunodeficiency.
* Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infectious endocarditis, cardiac malformation, rheumatic fever).
* Surgery within one month prior to inclusion (Visit 1/ week 0).
* Antibiotic prescription 1 week before inclusion (Visit 1/ week 0) and during run-in period (Visit 2/ week 2).
* Investigator's uncertainty about the willingness or ability of the infant's parents to comply with the protocol requirements.
* Participation in any other clinical trial within two weeks prior to entry into the study.

Primary outcomes:
measure: Safety and tolerance will be evaluated according to infant growth (weight, height and head circumference)
timeFrame: 12 weeks
measure: Adverse Event and/or Serious Adverse Event
timeFrame: 10 weeks
measure: Fecal characteristics
timeFrame: 10 weeks
measure: Use of medication
timeFrame: 12 weeks
Secondary outcomes:
measure: Urine concentration of D-lactic acid.
timeFrame: 12 weeks
measure: Changes in sleep and crying patterns
timeFrame: 10 weeks
measure: Immune compounds in fecal samples
timeFrame: 8 weeks
measure: Composition of fecal microbiota
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Felix Omeñaca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: