Healthy InfantsNCT07896083
Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation
A study testing Probiotic and Maltodextrin in people with Healthy Infants, run by BYHEALTH Co., LTD at 1 site in China.
Trial summary
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27) supplementation on immune function, growth and development, and gut microbiota composition. Read more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Probiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2025to 25 Aug 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 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Infants born at full term and aged 0-6 months, whose overall health condition was determined to be good by the researchers;
- 2. There are no restrictions on the mode of delivery and feeding methods;
- 3. Agree not to consume probiotics other than the tested product or formula milk powder containing probiotics during the study period;
- 4. Parents or legal guardians voluntarily participate in this clinical trial and sign the informed consent form.
Who cannot join
- 1. Suffering from severe acute or chronic coexisting diseases (cardiovascular, gastrointestinal, metabolic, endocrine, immune or any disease deemed contraindicated by the researchers);
- 2. Having a disease that might interfere with the researcher's observation of the normal development process of the infant's intestinal microecology. Such diseases include: acute infections (acute upper respiratory tract infection, acute diarrhea, etc.); autoimmune diseases (such as ulcerative colitis, Crohn's disease, etc.); intestinal surgeries (intussusception, intestinal obstruction, endoscopic examination, etc.), major surgeries (post-surgery for congenital heart disease, etc.), genetic metabolic diseases (such as cystic fibrosis), burns and severe trauma, energy metabolism-related diseases (diabetes, cerebral palsy, etc.), premature birth, tumors, diseases with abnormal intestinal structure development (megacolon, gastric torsion, etc.);
- 3. Having consumed probiotics or formula milk containing probiotics in the past two weeks;
- 4. Having used antibiotics in the past two months;
- 5. Having participated in drug clinical research in the past three months;
- 6. Refusing random grouping.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Dalian University
Dalian, Liaoning, 116000
Ming Li, 180 1892 3363 ext. +86, vivianmarat@163.com
About this study
Official title: Study on the Effects of Lactobacillus Paracasei LPB27 on Infant Gut Microbiota and Immune Regulation
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27) supplementation on immune function, growth and development, and gut microbiota composition. The secondary objective is to assess its effects on defecation characteristics and gastrointestinal symptoms (bloating, diarrhea, abdominal pain).
- Conditions
- Healthy Infants
- Being tested
- Probiotic, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Continuous intervention for 84 days.
MaltodextrinDietary supplement
Continuous intervention for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| LPB27 Probiotic Group | Experimental | Participants take one 1-g sachet daily for 84 days, providing at least 1 × 10^10 colony-forming units (CFU) of Lacticaseibacillus paracasei LPB27 (strain 207-27) per sachet. The powder may be mixed with water at a temperature not exceeding 40°C or added to milk before consumption. Receives: Dietary Supplement: Probiotic |
| Maltodextrin Placebo Group | Placebo comparator | Participants take one 1-g sachet of maltodextrin daily for 84 days, using the same packaging and administration method as the LPB27 intervention. Receives: Dietary Supplement: Maltodextrin |
| Breastfeeding Observation Group | No intervention | Participants receive no study supplement and undergo observation and follow-up according to the study schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Secretory Immunoglobulin A (sIgA) Concentration
Fecal sIgA concentration measured in feces samples at each assessment time point using Enzyme-linked Immunosorbent Assay (ELISA). Results will be reported as absolute concentrations in μg/g.
Measured: Baseline (Week 0), Week 12, Week 24.
Body Weight
Body weight measured at each assessment time point and reported as an absolute value in kg.
Measured: Baseline (Week 0), Week 12, Week 24.
Body Length
Body length measured at each assessment time point and reported as an absolute value in cm.
Measured: Baseline (Week 0), Week 12, Week 24.
Head Circumference
Head circumference measured at each assessment time point and reported as an absolute value in cm.
Measured: Baseline (Week 0), Week 12, Week 24.
Gut microbiota composition
Relative abundance of fecal microbial taxa determined by 16S rRNA (rRNA) gene sequencing and reported as a percentage of sequencing reads at each assessment time point, especially the relative abundances of Lactobacillus and Bifidobacterium.
Measured: Baseline (Week 0), Week 12, Week 24.
Secondary outcomes (5)
Stool Amount
Stool amount assessed based on the proportion of the diaper surface area covered by stool for each recorded bowel movement. Stool amount will be categorized into three levels: less than 25% of the diaper surface area covered by stool, 25%-50% covered, and more than 50% covered. The percentage of stool records in each category will be summarized for each assessment period.
Measured: Baseline (Week 0), Week 12, Week 24.
Occurrence of Abdominal Bloating
Incidence of abdominal bloating, assessed by a caregiver-reported symptom diary/questionnaire.
Measured: Baseline (Week 0), Week 12, Week 24.
Occurrence of Diarrhea
Incidence of diarrhea, assessed by a caregiver-reported symptom diary/questionnaire.
Measured: Baseline (Week 0), Week 12, Week 24.
Occurrence of Abdominal Pain
Incidence of abdominal pain, assessed by a caregiver-reported symptom diary/questionnaire.
Measured: Baseline (Week 0), Week 12, Week 24.
Fecal Short-Chain Fatty Acid (SCFA) Concentration
Total fecal SCFA concentration calculated as the sum of the concentrations of the prespecified individual SCFAs measured in fecal samples. Results will be reported as absolute concentrations in μmol/g at each assessment time point.
Measured: Baseline (Week 0), Week 12, Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start11 Oct 2025
- Primary completion11 Jul 2027 (estimated)
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BYHEALTH Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896083
- Sponsor's protocol ID
- BH2025001
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Lactobacillus Paracasei LPB27 on Infant Gut Microbiota and Immune Regulation
- ClinicalTrials.gov ID
- NCT07896083
- Acronym / sponsor ID
- BH2025001
- Conditions
- Healthy Infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- BYHEALTH Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 11 Jul 2027 (estimated)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 26 Oct 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.
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27) supplementation on immune function, growth and development, and gut microbiota composition. The secondary objective is to assess its effects on defecation characteristics and gastrointestinal symptoms (bloating, diarrhea, abdominal pain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LPB27 Probiotic Group | Experimental | Dietary Supplement: ProbioticParticipants take one 1-g sachet daily for 84 days, providing at least 1 × 10^10 colony-forming units (CFU) of Lacticaseibacillus paracasei LPB27 (strain 207-27) per sachet. The powder may be mixed with water at a temperature not exceeding 40°C or added to milk before consumption. |
| Maltodextrin Placebo Group | Placebo comparator | Dietary Supplement: MaltodextrinParticipants take one 1-g sachet of maltodextrin daily for 84 days, using the same packaging and administration method as the LPB27 intervention. |
| Breastfeeding Observation Group | No intervention | –Participants receive no study supplement and undergo observation and follow-up according to the study schedule. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Infants born at full term and aged 0-6 months, whose overall health condition was determined to be good by the researchers;
- 2. There are no restrictions on the mode of delivery and feeding methods;
- 3. Agree not to consume probiotics other than the tested product or formula milk powder containing probiotics during the study period;
- 4. Parents or legal guardians voluntarily participate in this clinical trial and sign the informed consent form.
Key exclusion criteria (6 listed)
- 1. Suffering from severe acute or chronic coexisting diseases (cardiovascular, gastrointestinal, metabolic, endocrine, immune or any disease deemed contraindicated by the researchers);
- 2. Having a disease that might interfere with the researcher's observation of the normal development process of the infant's intestinal microecology. Such diseases include: acute infections (acute upper respiratory tract infection, acute diarrhea, etc.); autoimmune diseases (such as ulcerative colitis, Crohn's disease, etc.); intestinal surgeries (intussusception, intestinal obstruction, endoscopic examination, etc.), major surgeries (post-surgery for congenital heart disease, etc.), genetic metabolic diseases (such as cystic fibrosis), burns and severe trauma, energy metabolism-related diseases (diabetes, cerebral palsy, etc.), premature birth, tumors, diseases with abnormal intestinal structure development (megacolon, gastric torsion, etc.);
- 3. Having consumed probiotics or formula milk containing probiotics in the past two weeks;
- 4. Having used antibiotics in the past two months;
- 5. Having participated in drug clinical research in the past three months;
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 |
|---|---|---|
| ProbioticContinuous intervention for 84 days. | Dietary supplement | LPB27 Probiotic Group |
| MaltodextrinContinuous intervention for 84 days. | Dietary supplement | Maltodextrin Placebo Group |
Primary outcome
Fecal Secretory Immunoglobulin A (sIgA) Concentration
Time frame: Baseline (Week 0), Week 12, Week 24.
Fecal sIgA concentration measured in feces samples at each assessment time point using Enzyme-linked Immunosorbent Assay (ELISA). Results will be reported as absolute concentrations in μg/g.
Body Weight
Time frame: Baseline (Week 0), Week 12, Week 24.
Body weight measured at each assessment time point and reported as an absolute value in kg.
Body Length
Time frame: Baseline (Week 0), Week 12, Week 24.
Body length measured at each assessment time point and reported as an absolute value in cm.
Head Circumference
Time frame: Baseline (Week 0), Week 12, Week 24.
Head circumference measured at each assessment time point and reported as an absolute value in cm.
Gut microbiota composition
Time frame: Baseline (Week 0), Week 12, Week 24.
Relative abundance of fecal microbial taxa determined by 16S rRNA (rRNA) gene sequencing and reported as a percentage of sequencing reads at each assessment time point, especially the relative abundances of Lactobacillus and Bifidobacterium.
5 secondary outcomes
Stool Amount
Time frame: Baseline (Week 0), Week 12, Week 24.
Occurrence of Abdominal Bloating
Time frame: Baseline (Week 0), Week 12, Week 24.
Occurrence of Diarrhea
Time frame: Baseline (Week 0), Week 12, Week 24.
Occurrence of Abdominal Pain
Time frame: Baseline (Week 0), Week 12, Week 24.
Fecal Short-Chain Fatty Acid (SCFA) Concentration
Time frame: Baseline (Week 0), Week 12, Week 24.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Maltodextrin in people with Healthy Infants, run by BYHEALTH Co., LTD at 1 site in China.
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 6 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 26 Oct 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 China. 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 Ming Li (180 1892 3363 ext. +86, vivianmarat@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Secretory Immunoglobulin A (sIgA) Concentration (time frame: Baseline (Week 0), Week 12, Week 24.). The study lists 5 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 26 Oct 2026.