Back to resultsEffect of Probiotics on Infant's Fecal Microbiota Composition (BABYCARE)
Primary Purpose
Microbial Colonization
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Food Supplement 1
Food Supplement 2
Placebo
Sponsored by
About this trial
This is an interventional other trial for Microbial Colonization focused on measuring Probiotics, Infants, Microbiota
Eligibility Criteria
Inclusion Criteria:
- Healthy infants
- Age between 60 and 90 days
- Gestational age between 37 and 42 weeks
- Appropiate birth weight for gestational age (between P10 and P90)
- APGAR test score for birth normal at 1' and 5' of 7-10
- Whose parents accept the follow-up of the study procedures and sign the informed consent
Exclusion Criteria:
- Infants participating in other clinical study
- Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
- Infants who have taken antibiotics 4 weeks prior the start study
- Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
- Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
- Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
- TORCH complex infections
- Every other diseases related with the immune system
- Parents who can not accomplish the follow-up of the study (medical criterium)
Sites / Locations
- Clínica Viamed MontecanalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Experimental 1
Experimental 2
Placebo
Arm Description
Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Sunflower oil
Outcomes
Primary Outcome Measures
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
Secondary Outcome Measures
Weight change
Change in weight (g per day) between day 0 and month 3
Length change
Change in length (cm) between day 0 and month 3
Head circumference change
Change in head circumference (cm) between day 0 and month 3
BMI change
Change in BMI (kg/m2) between day 0 and month 3
Frequency of depositions
Frequency of depositions (number stools/day) documented in participants diary
Consistency of stools
Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid
Infant colic
Incidence of infant colic, defined as prolonged and recurrent periods of crying, agitation, or irritability without apparent cause that cannot be prevented or resolved by your caregivers, for three or more hours daily for three or more days a week
Vomiting
Incidence of vomiting (n/day)
Sleeping habits
Nocturnal sleeping (min/day), total sleeping hours (min/day)
Incidence of infections
Number and duration (in days) of any type of infectious episodes
Fever
Number of days with fever (axial body temperature higher than 37.5 ºC)
Antibiotics
Number of days with antibiotic treatment
Change in fecal microbiota composition
Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing
sIgA in stool samples
Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA
Calprotectin
Analysis of fecal calprotectin through ELISA
Full Information
NCT ID
NCT05524649
First Posted
August 26, 2022
Last Updated
October 11, 2023
Sponsor
AB Biotics, SA
Collaborators
Centre for the Development of Industrial Technology, Ministry of Science and Innovation, Spain
1. Study Identification
Unique Protocol Identification Number
NCT05524649
Brief Title
Effect of Probiotics on Infant's Fecal Microbiota Composition
Acronym
BABYCARE
Official Title
Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Biotics, SA
Collaborators
Centre for the Development of Industrial Technology, Ministry of Science and Innovation, Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Detailed Description
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
Probiotics, Infants, Microbiota
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, placebo-controlled trial in 120 healthy infants between 60 and 90 days of age, who will be allocated to receive either one of the probiotic strains or placebo for 3 months
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Every product will be provided in identical packaging
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sunflower oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Food Supplement 1
Intervention Description
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Food Supplement 2
Intervention Description
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
5 drops/day for 3 months of sunflower oil
Primary Outcome Measure Information:
Title
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
Description
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
Time Frame
day 0, month 3
Secondary Outcome Measure Information:
Title
Weight change
Description
Change in weight (g per day) between day 0 and month 3
Time Frame
day 0, month 1, month 2, month 3
Title
Length change
Description
Change in length (cm) between day 0 and month 3
Time Frame
day 0, month 1, month 2, month 3
Title
Head circumference change
Description
Change in head circumference (cm) between day 0 and month 3
Time Frame
day 0, month 1, month 2, month 3
Title
BMI change
Description
Change in BMI (kg/m2) between day 0 and month 3
Time Frame
day 0, month 1, month 2, month 3
Title
Frequency of depositions
Description
Frequency of depositions (number stools/day) documented in participants diary
Time Frame
day 0, month 1, month 2, month 3
Title
Consistency of stools
Description
Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid
Time Frame
day 0, month 1, month 2, month 3
Title
Infant colic
Description
Incidence of infant colic, defined as prolonged and recurrent periods of crying, agitation, or irritability without apparent cause that cannot be prevented or resolved by your caregivers, for three or more hours daily for three or more days a week
Time Frame
day 0, month 1, month 2, month 3
Title
Vomiting
Description
Incidence of vomiting (n/day)
Time Frame
day 0, month 1, month 2, month 3
Title
Sleeping habits
Description
Nocturnal sleeping (min/day), total sleeping hours (min/day)
Time Frame
day 0, month 1, month 2, month 3
Title
Incidence of infections
Description
Number and duration (in days) of any type of infectious episodes
Time Frame
day 0, month 1, month 2, month 3
Title
Fever
Description
Number of days with fever (axial body temperature higher than 37.5 ºC)
Time Frame
day 0, month 1, month 2, month 3
Title
Antibiotics
Description
Number of days with antibiotic treatment
Time Frame
day 0, month 1, month 2, month 3
Title
Change in fecal microbiota composition
Description
Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing
Time Frame
day 0, month 3
Title
sIgA in stool samples
Description
Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA
Time Frame
day 0, month 3
Title
Calprotectin
Description
Analysis of fecal calprotectin through ELISA
Time Frame
day 0, month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy infants
Age between 60 and 90 days
Gestational age between 37 and 42 weeks
Appropiate birth weight for gestational age (between P10 and P90)
APGAR test score for birth normal at 1' and 5' of 7-10
Whose parents accept the follow-up of the study procedures and sign the informed consent
Exclusion Criteria:
Infants participating in other clinical study
Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
Infants who have taken antibiotics 4 weeks prior the start study
Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
TORCH complex infections
Every other diseases related with the immune system
Parents who can not accomplish the follow-up of the study (medical criterium)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo Rodríguez Martínez, MD
Phone
654633910
Ext
+34
Email
gerard@unizar.es
First Name & Middle Initial & Last Name or Official Title & Degree
Meritxell Aguilo Garcia, PhD
Phone
+34902903844
Email
aguilo@ab-biotics.com
Facility Information:
Facility Name
Clínica Viamed Montecanal
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerardo Rodríguez Martínez, MD
Phone
654633910
Ext
+34
Email
gerard@unizar.es
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34568236
Citation
Chen K, Liu C, Li H, Lei Y, Zeng C, Xu S, Li J, Savino F. Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Pediatr. 2021 Sep 10;9:635176. doi: 10.3389/fped.2021.635176. eCollection 2021.
Results Reference
background
PubMed Identifier
21150647
Citation
Braegger C, Chmielewska A, Decsi T, Kolacek S, Mihatsch W, Moreno L, Piescik M, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2011 Feb;52(2):238-50. doi: 10.1097/MPG.0b013e3181fb9e80.
Results Reference
background
PubMed Identifier
32727119
Citation
Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
Results Reference
background
PubMed Identifier
32443684
Citation
Castanet M, Costalos C, Haiden N, Hascoet JM, Berger B, Sprenger N, Grathwohl D, Brussow H, De Groot N, Steenhout P, Pecquet S, Benyacoub J, Picaud JC. Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial. Nutrients. 2020 May 20;12(5):1481. doi: 10.3390/nu12051481.
Results Reference
result
PubMed Identifier
26832746
Citation
Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
Results Reference
result
PubMed Identifier
28002391
Citation
Radke M, Picaud JC, Loui A, Cambonie G, Faas D, Lafeber HN, de Groot N, Pecquet SS, Steenhout PG, Hascoet JM. Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial. Pediatr Res. 2017 Apr;81(4):622-631. doi: 10.1038/pr.2016.270. Epub 2016 Dec 21. Erratum In: Pediatr Res. 2018 Jan;83(1-1):190.
Results Reference
result
Learn more about this trial
Effect of Probiotics on Infant's Fecal Microbiota Composition
We'll reach out to this number within 24 hrs