Functional Gastrointestinal Disorders (FGIDs)NCT07320287
Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
A study testing RO water, LiveSpo PREG-MOM and LiveSpo CONSY in people with Functional Gastrointestinal Disorders (FGIDs) and Weight Loss, run by Anabio R&D at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders (FGIDs), Weight Loss
- What is being tested?
- RO water, LiveSpo PREG-MOM and LiveSpo CONSY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteVietnam
- Study dates
- 26 Jan 2026to 7 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- For the neonate:
- 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.
- Known allergy or intolerance to any component of the investigational product.
Show all 12Show fewer
- Concurrent participation in another interventional clinical trial.
- The investigators judge the neonate to be unsuitable for participation.
- Parent(s) or legal guardian(s) who do not comply with study requirements or refuse to sign the informed consent.
- For the mother:
- Mother diagnosed with a serious or unstable medical condition involving the hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine/metabolic, or psychiatric systems.
- Mother who intends to use, or is prescribed, any other probiotic/prebiotic product for herself or the infant during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Obstetrics and Gynecology Hospital
Hanoi
Hue TK Ta, (+84) 972467431, huettkpshn@gmail.com
About this study
Official title: A Randomized, Blinded, Controlled Trial to Evaluate Effects of Multi-strain Bacillus Spore Probiotic Supplements (LiveSpo PREG-MOM and LiveSpo CONSY) on Growth Metrics, Prevention of Functional Gastrointestinal Disorders, and Modulation of the Gut Microbiota in Cesarean-Delivered Neonates
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.
Read more
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
Read the detailed description
Infants delivered by cesarean section commonly experience early differences in feeding and distinct patterns of gut microbial development compared with infants born vaginally. Because cesarean delivery limits contact with maternal vaginal microbiota, which is an important source of early microbial transfer, these infants often show delayed establishment of key early colonizers. Multiple cohort studies have documented lower abundances of beneficial genera such as Bifidobacterium and Bacteroides, along with relatively higher proportions of Proteobacteria during the first months of life. This shift in microbial composition has been associated with functional gastrointestinal symptoms in early infancy, including regurgitation, colic, abdominal discomfort, and changes in stool frequency and consistency. Such symptoms can affect feeding patterns, contribute to variations in weight gain, and influence overall gastrointestinal functioning during the neonatal period. As cesarean delivery rates continue to rise in Vietnam, there is increasing interest in supportive approaches that may help promote gastrointestinal functioning and healthier gut microbial development in this group.
Probiotic supplementation during early infancy has been explored as a potential strategy to support gut microbial maturation. Spore-forming Bacillus strains, belonging to safe B. subtilis, B. clausii, and B. coagulans species, are notable for their stability and ability to survive passage through the digestive tract. These characteristics allow them to reach the intestine in viable form, where they may interact with the developing gut ecosystem. Prior pediatric studies of Bacillus preparations have reported favorable safety profiles and signals of benefit for digestive conditions, although findings vary depending on strain and study design. Multi-strain products may offer complementary biological functions, providing broader support for the developing gut environment.
Based on this scientific background, the present study has been designed to evaluate two oral Bacillus spore probiotic formulations of B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40, LiveSpo PREG-MOM (3 billion spores per 5 mL) and LiveSpo CONSY (4 billion spores per 5 mL), in cesarean-delivered infants. The study aims to evaluate whether daily supplementation during the first 90 days of life influences early growth trajectories, the occurrence of functional gastrointestinal disturbances, immune indicators in stool, and the development of gut microbial communities. The study will also assess the presence of probiotic spores in stool as an indicator of product use compliance.
This investigation is a randomized, blind, controlled clinical trial conducted at Hanoi Obstetrics and Gynecology Hospital. A total of 180 healthy full-term infants (38-40 weeks' gestation) delivered by cesarean section will be enrolled after parental consent. Eligible infants will be randomly assigned in equal numbers to one of three groups: Placebo (RO water), Pregmom (LiveSpo PREG-MOM), or Consy (LiveSpo CONSY). Randomization will use permuted blocks to help maintain balanced allocation across groups, and all products will be provided in identical coded ampoules to ensure blinding of families, clinical staff, and laboratory personnel.
Participants will receive one 5-mL ampoule of the assigned product once daily for 90 days. Clinical assessments will be performed at baseline and on days 2, 9, 30, 60, and 90. These assessments include measurements of weight, length, and head circumference, along with documentation of digestive patterns such as stool frequency, stool characteristics, regurgitation…, using structured observation tools suitable for young infants.
Stool samples will be collected at days 0, 2, 9, 30, 60, and 90 for laboratory evaluation. Real-time polymerase chain reaction (PCR) assays will be used to detect spores of B. subtilis, B. clausii, and B. coagulans, providing information on product exposure in the probiotic groups and verifying the absence of these strains in the placebo group. Stool samples collected on days 0, 9, and 30 will undergo enzyme-linked immunosorbent assay (ELISA)-based measurement of immune-related indicators, including pro- and anti-inflammatory cytokines, calprotectin, and immunoglobulin A (IgA), which may reflect aspects of intestinal immune activity. To investigate early microbial development, a subset of approximately 10-15 infants per group will undergo 16S ribosomal ribonucleic acid (rRNA) gene sequencing on stool samples collected at day 0 and day 30.
All data will be recorded in study-specific case report forms or electronic case report forms. Statistical analyses appropriate for categorical and continuous variables, as well as repeated measurements, will be applied according to the overall study objectives. The intervention period, scheduled follow-up visits, and data analysis will be completed within the 12-month study timeline.
Through the combined evaluation of growth patterns, digestive observations, immune indicators in stool, and microbiota profiles, this study aims to provide comprehensive evidence on the potential role of multi-strain Bacillus spore probiotics as a supportive option for infants born by cesarean delivery.
- Being tested
- RO water, LiveSpo PREG-MOM, LiveSpo CONSY
- Keywords
- Cesarean-born Infants, Gut Dysbiosis, Bacillus spore
- Medical subject headings
- Gastrointestinal Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO waterOther
RO 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-MOMCombination product
LiveSpo PREG-MOM has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.
LiveSpo CONSYCombination product
LiveSpo CONSY has a registration number 4165/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | The Placebo group receives reverse osmosis (RO) water with a dosage of 1 ampoule per day for 90 days. Receives: Other: RO water |
| Pregmom group | Experimental | The Pregmom group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU/5 mL (LiveSpo PREG-MOM) with a dosage of 1 ampoule per day for 90 days. Receives: Combination Product: LiveSpo PREG-MOM |
| Consy group | Experimental | The Consy group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 4 billion CFU/5 mL (LiveSpo CONSY) with a dosage of 1 ampoule per day for 90 days. Receives: Combination Product: LiveSpo CONSY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 0, 2, 9, 30, 60, and 90
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.
Measured: Days 0, 2, 9, 30, 60, and 90
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.
Measured: Days 0, 2, 9, 30, 60, and 90
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.
Measured: Days 0, 2, 9, 30, 60, and 90
Secondary outcomes (5)
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).
Measured: Days 0, 2, 9, 30, 60, and 90
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).
Measured: Days 0, 30, 60, and 90
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).
Measured: Days 0, 30, 60, and 90
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)
Measured: Days 0, 9, and 30
Gut microbiota composition
Changes in gut microbiota composition assessed by 16S rRNA gene sequencing of stool infants samples. Outcomes include diversity indices and relative taxonomic composition at major taxonomic levels (for example, phylum, family, genus) at day 30 compared with day 0
Measured: Days 0 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start26 Jan 2026
- Primary completion7 Dec 2026 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal Disorders (FGIDs)Studies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anabio R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanoi Obstetrics and Gynecology Hospital
- Responsible party
- Sponsor
- Investigators
- Hung T Mai, PhD, Principal investigator, Hanoi Obstetrics and Gynecology HospitalChuong C Nguyen, Study chair, Hanoi Obstetrics and Gynecology HospitalAnh TV Nguyen, Assoc.Prof.PhD, Study chair, Anabio R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320287
- Sponsor's protocol ID
- TNLS.2025.NB
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party
Publications
Long G, Hu Y, Tao E, Chen B, Shu X, Zheng W, Jiang M. The Influence of Cesarean Section on the Composition and Development of Gut Microbiota During the First 3 Months of Life. Front Microbiol. 2021 Aug 18;12:691312. doi: 10.3389/fmicb.2021.691312. eCollection 2021.
PubMed 34489887Kelly NM, Keane JV, Gallimore RB, Bick D, Tribe RM. Neonatal weight loss and gain patterns in caesarean section born infants: integrative systematic review. Matern Child Nutr. 2020 Apr;16(2):e12914. doi: 10.1111/mcn.12914. Epub 2019 Nov 27.
PubMed 31777183Ianiro G, Rizzatti G, Plomer M, Lopetuso L, Scaldaferri F, Franceschi F, Cammarota G, Gasbarrini A. Bacillus clausii for the Treatment of Acute Diarrhea in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2018 Aug 12;10(8):1074. doi: 10.3390/nu10081074.
PubMed 30103531Gong Y, Zhong H, Wang J, Wang X, Huang L, Zou Y, Qin H, Yang R. Effect of Probiotic Supplementation on the Gut Microbiota Composition of Infants Delivered by Cesarean Section: An Exploratory, Randomized, Open-label, Parallel-controlled Trial. Curr Microbiol. 2023 Sep 15;80(11):341. doi: 10.1007/s00284-023-03444-4.
PubMed 37712964Delfino E, Peano L, Wetzl RG, Gianni ML, Netto R, Consales A, Bettinelli ME, Morniroli D, Vielmi F, Mosca F, Montagnani L. Newborn Weight Loss as a Predictor of Persistence of Exclusive Breastfeeding up to 6 Months. Front Pediatr. 2022 Apr 7;10:871595. doi: 10.3389/fped.2022.871595. eCollection 2022.
PubMed 35463877Colom J, Freitas D, Simon A, Brodkorb A, Buckley M, Deaton J, Winger AM. Presence and Germination of the Probiotic Bacillus subtilis DE111(R) in the Human Small Intestinal Tract: A Randomized, Crossover, Double-Blind, and Placebo-Controlled Study. Front Microbiol. 2021 Aug 2;12:715863. doi: 10.3389/fmicb.2021.715863. eCollection 2021.
PubMed 34408741Bernardeau M, Lehtinen MJ, Forssten SD, Nurminen P. Importance of the gastrointestinal life cycle of Bacillus for probiotic functionality. J Food Sci Technol. 2017 Jul;54(8):2570-2584. doi: 10.1007/s13197-017-2688-3. Epub 2017 May 23.
PubMed 28740315
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Controlled Trial to Evaluate Effects of Multi-strain Bacillus Spore Probiotic Supplements (LiveSpo PREG-MOM and LiveSpo CONSY) on Growth Metrics, Prevention of Functional Gastrointestinal Disorders, and Modulation of the Gut Microbiota in Cesarean-Delivered Neonates
- ClinicalTrials.gov ID
- NCT07320287
- Acronym / sponsor ID
- TNLS.2025.NB
- Keywords
- Cesarean-born Infants, Gut Dysbiosis, Bacillus spore
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Anabio R&DIndustry (pharma, biotech, devices)
- Collaborators
- Hanoi Obstetrics and Gynecology Hospital
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 7 Dec 2026 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- 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.
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
Detailed description
Infants delivered by cesarean section commonly experience early differences in feeding and distinct patterns of gut microbial development compared with infants born vaginally. Because cesarean delivery limits contact with maternal vaginal microbiota, which is an important source of early microbial transfer, these infants often show delayed establishment of key early colonizers. Multiple cohort studies have documented lower abundances of beneficial genera such as Bifidobacterium and Bacteroides, along with relatively higher proportions of Proteobacteria during the first months of life. This shift in microbial composition has been associated with functional gastrointestinal symptoms in early infancy, including regurgitation, colic, abdominal discomfort, and changes in stool frequency and consistency. Such symptoms can affect feeding patterns, contribute to variations in weight gain, and influence overall gastrointestinal functioning during the neonatal period. As cesarean delivery rates continue to rise in Vietnam, there is increasing interest in supportive approaches that may help promote gastrointestinal functioning and healthier gut microbial development in this group.
Probiotic supplementation during early infancy has been explored as a potential strategy to support gut microbial maturation. Spore-forming Bacillus strains, belonging to safe B. subtilis, B. clausii, and B. coagulans species, are notable for their stability and ability to survive passage through the digestive tract. These characteristics allow them to reach the intestine in viable form, where they may interact with the developing gut ecosystem. Prior pediatric studies of Bacillus preparations have reported favorable safety profiles and signals of benefit for digestive conditions, although findings vary depending on strain and study design. Multi-strain products may offer complementary biological functions, providing broader support for the developing gut environment.
Based on this scientific background, the present study has been designed to evaluate two oral Bacillus spore probiotic formulations of B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40, LiveSpo PREG-MOM (3 billion spores per 5 mL) and LiveSpo CONSY (4 billion spores per 5 mL), in cesarean-delivered infants. The study aims to evaluate whether daily supplementation during the first 90 days of life influences early growth trajectories, the occurrence of functional gastrointestinal disturbances, immune indicators in stool, and the development of gut microbial communities. The study will also assess the presence of probiotic spores in stool as an indicator of product use compliance.
This investigation is a randomized, blind, controlled clinical trial conducted at Hanoi Obstetrics and Gynecology Hospital. A total of 180 healthy full-term infants (38-40 weeks' gestation) delivered by cesarean section will be enrolled after parental consent. Eligible infants will be randomly assigned in equal numbers to one of three groups: Placebo (RO water), Pregmom (LiveSpo PREG-MOM), or Consy (LiveSpo CONSY). Randomization will use permuted blocks to help maintain balanced allocation across groups, and all products will be provided in identical coded ampoules to ensure blinding of families, clinical staff, and laboratory personnel.
Participants will receive one 5-mL ampoule of the assigned product once daily for 90 days. Clinical assessments will be performed at baseline and on days 2, 9, 30, 60, and 90. These assessments include measurements of weight, length, and head circumference, along with documentation of digestive patterns such as stool frequency, stool characteristics, regurgitation…, using structured observation tools suitable for young infants.
Stool samples will be collected at days 0, 2, 9, 30, 60, and 90 for laboratory evaluation. Real-time polymerase chain reaction (PCR) assays will be used to detect spores of B. subtilis, B. clausii, and B. coagulans, providing information on product exposure in the probiotic groups and verifying the absence of these strains in the placebo group. Stool samples collected on days 0, 9, and 30 will undergo enzyme-linked immunosorbent assay (ELISA)-based measurement of immune-related indicators, including pro- and anti-inflammatory cytokines, calprotectin, and immunoglobulin A (IgA), which may reflect aspects of intestinal immune activity. To investigate early microbial development, a subset of approximately 10-15 infants per group will undergo 16S ribosomal ribonucleic acid (rRNA) gene sequencing on stool samples collected at day 0 and day 30.
All data will be recorded in study-specific case report forms or electronic case report forms. Statistical analyses appropriate for categorical and continuous variables, as well as repeated measurements, will be applied according to the overall study objectives. The intervention period, scheduled follow-up visits, and data analysis will be completed within the 12-month study timeline.
Through the combined evaluation of growth patterns, digestive observations, immune indicators in stool, and microbiota profiles, this study aims to provide comprehensive evidence on the potential role of multi-strain Bacillus spore probiotics as a supportive option for infants born by cesarean delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: RO waterThe Placebo group receives reverse osmosis (RO) water with a dosage of 1 ampoule per day for 90 days. |
| Pregmom group | Experimental | Combination Product: LiveSpo PREG-MOMThe Pregmom group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU/5 mL (LiveSpo PREG-MOM) with a dosage of 1 ampoule per day for 90 days. |
| Consy group | Experimental | Combination Product: LiveSpo CONSYThe Consy group receives RO water plus B. subtilis, B. clausii, and B. coagulans at 4 billion CFU/5 mL (LiveSpo CONSY) with a dosage of 1 ampoule per day for 90 days. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Known allergy or intolerance to any component of the investigational product.
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 |
|---|---|---|
| RO waterRO 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. | Other | Placebo group |
| LiveSpo PREG-MOMLiveSpo PREG-MOM has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam. | Combination product | Pregmom group |
| LiveSpo CONSYLiveSpo CONSY has a registration number 4165/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam. | Combination product | Consy group |
Primary outcome
Change in stool frequency
Time frame: Days 0, 2, 9, 30, 60, and 90
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.
Change in stool consistency (Diapered Infant Stool Scale score)
Time frame: Days 0, 2, 9, 30, 60, and 90
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.
Change in regurgitation
Time frame: Days 0, 2, 9, 30, 60, and 90
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.
Change in crying episodes
Time frame: Days 0, 2, 9, 30, 60, and 90
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.
5 secondary outcomes
Change in infant body weight
Time frame: Days 0, 2, 9, 30, 60, and 90
Change in infant body length
Time frame: Days 0, 30, 60, and 90
Change in infant head circumference
Time frame: Days 0, 30, 60, and 90
Immune indicators in stool (cytokines and IgA)
Time frame: Days 0, 9, and 30
Gut microbiota composition
Time frame: Days 0 and 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 34489887Long G, Hu Y, Tao E, Chen B, Shu X, Zheng W, Jiang M. The Influence of Cesarean Section on the Composition and Development of Gut Microbiota During the First 3 Months of Life. Front Microbiol. 2021 Aug 18;12:691312. doi: 10.3389/fmicb.2021.691312. eCollection 2021.
- Background: PubMed 31777183Kelly NM, Keane JV, Gallimore RB, Bick D, Tribe RM. Neonatal weight loss and gain patterns in caesarean section born infants: integrative systematic review. Matern Child Nutr. 2020 Apr;16(2):e12914. doi: 10.1111/mcn.12914. Epub 2019 Nov 27.
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- Individual participant dataSharing planned: Yes. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party
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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.
Hung T Mai, PhD principal investigator
Hanoi Obstetrics and Gynecology Hospital
Chuong C Nguyen study chair
Hanoi Obstetrics and Gynecology Hospital
Anh TV Nguyen, Assoc.Prof.PhD study chair
Anabio R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RO water, LiveSpo PREG-MOM and LiveSpo CONSY in people with Functional Gastrointestinal Disorders (FGIDs) and Weight Loss, run by Anabio R&D at 1 site in Vietnam.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung T Mai, PhD ((+84) 988.855.888, bacsymaitronghung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool frequency (time frame: Days 0, 2, 9, 30, 60, and 90). 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?
On the ClinicalTrials.gov record for NCT07320287, which also lists 7 linked publications.
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 13 Aug 2026.