Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorAnabio R&D
About this trial
Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and increased Proteobacteria. This early microbial alteration has been associated with functional gastrointestinal disorders (FGIDs), including colic, regurgitation, and changes in stool frequency and consistency, which may in turn affect early growth and overall gastrointestinal functioning. Probiotic supplementation is considered a safe and feasible strategy to support microbial restoration and improve digestive function during the first months of life.
In this study, researchers propose that daily supplementation with multi-strain Bacillus spore probiotics may help support healthy early growth, reduce functional gastrointestinal symptoms, and promote a more balanced gut microbiota in cesarean-delivered infants.
The objective of this study is to evaluate the safety and efficacy of two oral probiotic formulations, LiveSpo PREG-MOM and LiveSpo CONSY, containing multi-strain B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40 at respective 3 and 4 billion colony-forming units (CFU)/5 mL ampoule, administered 1 ampoule daily, during the first 90 days of life. The study examines effects on growth, digestive symptoms, immune markers, and microbial composition.
Study Design: This randomized, blind, controlled clinical trial will enroll 180 healthy full-term cesarean-born infants at Hanoi Obstetrics and Gynecology Hospital.
Intervention Description: Participants will be randomly assigned to three groups (n = 60 each). All groups will receive one 5-mL ampoule daily for 90 days: LiveSpo PREG-MOM, LiveSpo CONSY, or placebo. Stool samples will be collected at several follow-up time points to assess digestive health and microbial development. All products will be provided in blinded and coded packaging to maintain objectivity.
Study Duration: 12 months
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy term neonates delivered by cesarean section.
Infants were born at term, ranging from 38 to 40 weeks' gestation.
Birth weight appropriate for gestational age (AGA), defined as between the 10th and 90th percentiles for gestational age (≥P10 and ≤P90).
The infant's parent(s) or legal guardian(s) provide written informed consent and agree to comply with study procedures.
Disqualifiers
Multiple births (twins, triplets, etc.)
Birth weight outside the appropriate-for-gestational-age range: small for gestational age (SGA, < P10) or large for gestational age (LGA, > P90).
Major congenital abnormalities affecting the hematologic, hepatobiliary, cardiovascular, renal/urinary, or gastrointestinal systems; severe inborn errors of metabolism; or suspected primary immunodeficiency.
Prior exposure to systemic or enteral antibiotics (oral, IV, or IM) before the baseline assessment.
Trial design
Design model
Parallel
Treatments tested in this trial
RO water
Other interventionRO water (Aquafina, PepsiCo) produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM/CONSY but contain 5 mL of high-quality RO water from Aquafina.
LiveSpo PREG-MOM
Combination productLiveSpo PREG-MOM has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.
LiveSpo CONSY
Combination productLiveSpo CONSY has a registration number 4165/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Placebo groupPlacebo comparator 1 intervention
Group B: Pregmom groupExperimental treatment 1 intervention
Group C: Consy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in stool frequency
Change in daily stool frequency compared with baseline (day 0). Measurements at days 2, 9, 30, 60, and 90; days 2 and 9 serve as early supplementary timepoints.
Time frame
Days 0, 2, 9, 30, 60, and 902
Change in stool consistency (Diapered Infant Stool Scale score)
Change in stool consistency using the Diapered Infant Stool Scale (type 1-type 5) compared with baseline (day 0). Measurements at days 2, 9, 30, 60, and 90; days 2 and 9 serve as early supplementary timepoints.
Time frame
Days 0, 2, 9, 30, 60, and 903
Change in regurgitation
Change in regurgitation assessed by both frequency (number of regurgitation episodes per day) and severity (caregiver-reported severity), compared with baseline (day 0). Measurements will be obtained at days 2, 9, 30, 60, and 90; days 2 and 9 serve as early supplementary timepoints.
Time frame
Days 0, 2, 9, 30, 60, and 904
Change in crying episodes
Change in the number of crying episodes per day compared with baseline (day 0). Measurements at days 2, 9, 30, 60, and 90; days 2 and 9 serve as early supplementary timepoints.
Time frame
Days 0, 2, 9, 30, 60, and 90Secondary outcomes
1
Change in infant body weight
Change in infant body weight (kg), and expressed as age-appropriate Z-scores based on WHO growth standards. Measurements at days 2, 9, 30, 60, and 90 will be compared with baseline (day 0).
Time frame
Days 0, 2, 9, 30, 60, and 902
Change in infant body length
Change in infant body length (cm), and expressed as age-appropriate Z-scores based on WHO growth standards. Measurements at days 30, 60, and 90 will be compared with baseline (day 0).
Time frame
Days 0, 30, 60, and 903
Change in infant head circumference
Change in infant head circumference (cm) and expressed as age-appropriate Z-scores based on WHO growth standards. Measurements at days 30, 60, and 90 will be compared with baseline (day 0).
Time frame
Days 0, 30, 60, and 904
Immune indicators in stool (cytokines and IgA)
Changes in immune indicators measured in stool samples, including concentrations of selected pro-inflammatory and anti-inflammatory cytokines (for example, IL-1β, TNF-α, IL-6, IL-8, IL-10, IL-17) (µg/mL) and secretory IgA (µg/mL). Values at days 9 and 30 will be compared with baseline (day 0)
Time frame
Days 0, 9, and 30Other outcomes
1
Fecal calprotectin levels
Changes in fecal calprotectin concentrations as an exploratory marker of intestinal inflammation, with values at days 9 and 30 compared with baseline.
Time frame
Days 0, 9, and 302
Use of antibiotics during the study period
Use of systemic antibiotics over the 90-day follow-up, including the proportion of infants receiving at least one antibiotic course or/and the number of antibiotic courses per infant or/and the duration (days) of each antibiotic course. Information is collected at scheduled follow-up visits and summarized across the entire study period.
Time frame
Day 0 to Day 903
Detection of probiotic Bacillus spores in stool
Presence of B. subtilis, B. clausii, and B. coagulans spores in stool as determined by real-time PCR, used as an exploratory indicator of exposure to the assigned probiotic products and adherence to the intervention across follow-up timepoints.
Time frame
Day 0 to Day 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anabio R&D
Lead sponsor
Hanoi Obstetrics and Gynecology Hospital
Collaborator
Source ClinicalTrials.gov