Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial.
Ke Chen, Changqi Liu, Hua Li...
https://pubmed.ncbi.nlm.nih.gov/34568236Actively Recruiting
Phase Not Applicable
Age: 1Day - 90Days
All Genders
Healthy Volunteers
ID05524649
Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
Led by AB Biotics, SA · Updated on 2025-02-11
120
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
AB Biotics, SA
Lead Sponsor
M
Ministry of Science and Innovation, Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, double-blind, placebo-controlled clinical trial to study the effects of two probiotic strains, Bifidobacterium longum and Pediococcus pentosaceus, on the fecal microbiota composition of healthy infants. The study also evaluates secondary outcomes such as growth measurements, digestive health, sleeping patterns, infection rates, allergic reactions, safety, and tolerability of the probiotics. The trial is sponsored by AB Biotics, SA and focuses on infants aged 1 to 90 days. Participants will be randomly assigned to one of three groups for three months: one group will receive Bifidobacterium longum in a liquid formulation suspended in sunflower oil, another group will receive Pediococcus pentosaceus in the same format, and the third will receive a placebo of sunflower oil. Each infant will receive five drops daily. Both probiotic strains have Qualified Presumption of Safety status by the European Food Safety Authority. During the study, infants will be monitored at baseline and monthly for three months. Assessments will include changes in fecal microbiota composition, growth parameters (weight, length, head circumference, BMI), stool frequency and consistency, digestive tolerance, sleep habits, incidence of infections, fever, antibiotic use, and adverse events. Stool samples will be analyzed for immune markers like sIgA and calprotectin. The total participation lasts three months with safety and tolerability closely observed throughout.
CONDITIONS
Brief Title
Effect of Probiotics on Infant's Fecal Microbiota Composition
Who Can Participate
Age: 1Day - 90Days
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy infants
- Age between 1 and 90 days
- Gestational age between 37 and 42 weeks
- Appropriate birth weight for gestational age (between P10 and P90)
- Normal APGAR score of 7-10 at 1 and 5 minutes after birth
- Parents agree to follow-up and sign informed consent
You will not qualify if you...
- Participation in another clinical study
- Use of infant formula containing probiotics or probiotic supplements within 4 weeks before study start
- Use of antibiotics within 4 weeks before study start
- Infants with cow's milk protein allergy, lactose intolerance, or other digestive diseases
- Maternal history of neurological disorders, metabolic diseases, type 1 diabetes, chronic disease, or malnutrition during pregnancy
- Acute congenital or acquired diseases affecting growth or feeding
- TORCH complex infections
- Immune system related diseases
- Parents unable to comply with study follow-up (medical discretion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive a daily probiotic or placebo supplement for 3 months to study its effect on infant fecal microbiota composition.
Monthly visits for 3 months
Trial Site Locations
Total: 2 locations
1
Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
Alcaldía Coyoacán, Puebla, Mexico, 04530
Not Yet Recruiting
2
Clínica Viamed Montecanal
Zaragoza, Aragon, Spain, 50012
Actively Recruiting
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Research Team
G
Gerardo Rodríguez Martínez, MD
M
Meritxell Aguilo Garcia, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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Published Research Related To This Trial
Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition.
Christian Braegger, Anna Chmielewska, Tamas Decsi...
https://pubmed.ncbi.nlm.nih.gov/21150647Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease.
Elisabet Navarro-Tapia, Giorgia Sebastiani, Sebastian Sailer...
https://pubmed.ncbi.nlm.nih.gov/32727119Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial.
Mireille Castanet, Christos Costalos, Nadja Haiden...
https://pubmed.ncbi.nlm.nih.gov/32443684Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial.
Yana Emmy Hoy-Schulz, Kaniz Jannat, Thomas Roberts...
https://pubmed.ncbi.nlm.nih.gov/26832746Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial.
Michael Radke, Jean-Charles Picaud, Andrea Loui...
https://pubmed.ncbi.nlm.nih.gov/28002391