An interventional study of Probiotic and Maltodextrin in Healthy Infants, sponsored by BYHEALTH Co., LTD. Completed at 1 site in China. Open to participants aged 0 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by BYHEALTH Co., LTD · Not applicable, Interventional, and Prevention
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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).
This is the only study on the registry with BYHEALTH Co., LTD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 13, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Probiotic
Participants take one 1-g sachet of maltodextrin daily for 84 days, using the same packaging and administration method as the LPB27 intervention.
Dietary Supplement: Maltodextrin
Participants receive no study supplement and undergo observation and follow-up according to the study schedule.
Continuous intervention for 84 days.
Continuous intervention for 84 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), Week 12, Week 24.
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.
Time frame: Baseline (Week 0), Week 12, Week 24.
Occurrence of Abdominal Bloating
Incidence of abdominal bloating, assessed by a caregiver-reported symptom diary/questionnaire.
Time frame: Baseline (Week 0), Week 12, Week 24.
Occurrence of Diarrhea
Incidence of diarrhea, assessed by a caregiver-reported symptom diary/questionnaire.
Time frame: Baseline (Week 0), Week 12, Week 24.
Occurrence of Abdominal Pain
Incidence of abdominal pain, assessed by a caregiver-reported symptom diary/questionnaire.
Time frame: 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.
Time frame: Baseline (Week 0), Week 12, Week 24.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2025 to primary completion in Jun 2026, 8 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 13, 2026: primary completion Jul 2027 → Jun 2026 and completion Aug 2027 → Jun 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic