Body WeightPROBINFANTNCT02215304
Safety and Tolerance Study of Three Probiotic Strains in Infants
A study testing Bifidobacterium longum ssp infantis R0033, Lactobacillus helveticus R0052 and Bifidobacterium bifidum R0071 in people with Body Weight and Body Height, run by ProbiSearch SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Body Height, Head Circumference
- What is being tested?
- Bifidobacterium longum ssp infantis R0033, Lactobacillus helveticus R0052 and Bifidobacterium bifidum R0071
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Jul 2015
- 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 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants between 3-12 months old
- Written informed consent from at least one parent or the legal tutor.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Body Weight, Body Height, Head Circumference
- Being tested
- Bifidobacterium longum ssp infantis R0033, Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Placebo
- Keywords
- Dietary supplementation, Probiotics, Safety/Efficiency, Healthy infants
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longum ssp infantis R0033Dietary supplement
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)
Lactobacillus helveticus R0052Dietary supplement
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)
Bifidobacterium bifidum R0071Dietary supplement
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)
PlaceboDietary supplement
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)
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium longum R0033 | Active comparator | Bifidobacterium longum ssp infantis R0033, 3*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks Receives: Dietary Supplement: Bifidobacterium longum ssp infantis R0033 |
| Lactobacillus helveticus R0052 | Active comparator | Lactobacillus helveticus R0052, 3*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks Receives: Dietary Supplement: Lactobacillus helveticus R0052 |
| Bifidobacterium bifidum R0071 | Active comparator | Bifidobacterium bifidum R0071, 3*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks Receives: Dietary Supplement: Bifidobacterium bifidum R0071 |
| Placebo | Placebo comparator | potato starch 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance will be evaluated according to infant growth (weight, height and head circumference)
growth will be evaluated considering weight, height and head circumference, at four different time points during study: 1st measure will be at screening visit (visit 1/week 0), 2nd measure will be after the run-in period and before starting intervention (visit 2/ week 2), 3rd measure will be after the eight weeks of intervention (visit 3/ week 10) and the 4th measure will be two weeks later (visit 4/week 12).
Measured: 12 weeks
Adverse Event and/or Serious Adverse Event
Adverse Event and/or Serious Adverse Event will be recorded daily by parents and notified to investigator within 24hrs., in particular gastro-intestinal symptoms, fever and rashes.
Measured: 10 weeks
Fecal characteristics
Fecal characteristics (stool frequency, stool consistency, stool amount and stool color) will be recorded daily by parents according to the "Amsterdam scale" and notified weekly to investigators.
Measured: 10 weeks
Use of medication
Medication used (antibiotics, etc) will be recorded daily by parents and notified weekly to investigators.
Measured: 12 weeks
Secondary outcomes (4)
Urine concentration of D-lactic acid.
D-lactic acid will be measured in urine samples at 4 different time points (weeks 0, 2, 10 and 12).
Measured: 12 weeks
Changes in sleep and crying patterns
Changes in sleep and crying patterns will be recorded daily by parents and notified weekly to investigators.
Measured: 10 weeks
Immune compounds in fecal samples
Immunoglobulins (Ig) A, G1, G2, G3, G4 and M, cytokines, chemokines and growth factors such as interleukins (IL) 1β, 2, 4, 5, 6, 7, 8, 10, 12, 13, and 17, interferon-γ (INF-γ), tumor necrosis factor-α (TNF-α), growth related oncogene-α (GRO-α), macrophages chemoattractant protein-1 (MCP-1), macrophages inflammatory protein-1β (MIP-1β), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophages colony stimulating factor (GM-CSF) and Calprotectin concentrations will be measured at two time points, before and after the study probiotic intake (weeks 0 and 10).
Measured: 8 weeks
Composition of fecal microbiota
Composition of fecal microbiota will be assessed at two different time points, before and after the intervention period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Felix Omeñaca, MD, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215304
- Sponsor's protocol ID
- LALLEM-001
- Acronym
- PROBINFANT
- Status last verified
- Dec 2016
- First submitted
- 11 Aug 2014
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Intervention Study to Assess the Safety and Tolerance Effect of Three Probiotic Strains in Infants
- ClinicalTrials.gov ID
- NCT02215304
- Acronym / sponsor ID
- PROBINFANT / LALLEM-001
- Conditions
- Body Weight, Body Height, Head Circumference
- Keywords
- Dietary supplementation, Probiotics, Safety/Efficiency, Healthy infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Collaborators
- Lallemand Health Solutions
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Aug 2014 (estimated)
- 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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium longum R0033 | Active comparator | Dietary Supplement: Bifidobacterium longum ssp infantis R0033Bifidobacterium longum ssp infantis R0033, 3*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks |
| Lactobacillus helveticus R0052 | Active comparator | Dietary Supplement: Lactobacillus helveticus R0052Lactobacillus helveticus R0052, 3*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks |
| Bifidobacterium bifidum R0071 | Active comparator | Dietary Supplement: Bifidobacterium bifidum R0071Bifidobacterium bifidum R0071, 3*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebopotato starch 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy term infants between 3-12 months old
- Written informed consent from at least one parent or the legal tutor.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| Bifidobacterium longum ssp infantis R003312 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) | Dietary supplement | Bifidobacterium longum R0033 |
| Lactobacillus helveticus R005212 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) | Dietary supplement | Lactobacillus helveticus R0052 |
| Bifidobacterium bifidum R007112 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) | Dietary supplement | Bifidobacterium bifidum R0071 |
| Placebo12 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) | Dietary supplement | Placebo |
Primary outcome
Safety and tolerance will be evaluated according to infant growth (weight, height and head circumference)
Time frame: 12 weeks
growth will be evaluated considering weight, height and head circumference, at four different time points during study: 1st measure will be at screening visit (visit 1/week 0), 2nd measure will be after the run-in period and before starting intervention (visit 2/ week 2), 3rd measure will be after the eight weeks of intervention (visit 3/ week 10) and the 4th measure will be two weeks later (visit 4/week 12).
Adverse Event and/or Serious Adverse Event
Time frame: 10 weeks
Adverse Event and/or Serious Adverse Event will be recorded daily by parents and notified to investigator within 24hrs., in particular gastro-intestinal symptoms, fever and rashes.
Fecal characteristics
Time frame: 10 weeks
Fecal characteristics (stool frequency, stool consistency, stool amount and stool color) will be recorded daily by parents according to the "Amsterdam scale" and notified weekly to investigators.
Use of medication
Time frame: 12 weeks
Medication used (antibiotics, etc) will be recorded daily by parents and notified weekly to investigators.
4 secondary outcomes
Urine concentration of D-lactic acid.
Time frame: 12 weeks
Changes in sleep and crying patterns
Time frame: 10 weeks
Immune compounds in fecal samples
Time frame: 8 weeks
Composition of fecal microbiota
Time frame: 8 weeks
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 14 Dec 2016.
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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.
Felix Omeñaca, MD, PhD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum ssp infantis R0033, Lactobacillus helveticus R0052 and Bifidobacterium bifidum R0071 in people with Body Weight and Body Height, run by ProbiSearch SL at 1 site in Spain.
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 2 inclusion and 9 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 14 Dec 2016. 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 Spain. 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?
Safety and tolerance will be evaluated according to infant growth (weight, height and head circumference) (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 14 Dec 2016.