A study on the effects of probiotic intervention on growth and development, and normal diseases in children
| ISRCTN | ISRCTN11762349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11762349 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Baoxing County Center for Disease Control and Prevention |
| Funder | Investigator initiated and funded |
- Submission date
- 07/11/2025
- Registration date
- 11/11/2025
- Last edited
- 11/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Probiotics are defined as "live microorganisms that, when administered in adequate amounts, confer a health benefit on the host." The intestinal microbiota of infants and toddlers undergoes rapid development within the first three years of life, and during this period, the stability of the intestinal flora is insufficient and is highly susceptible to changes in feeding methods and the environment. Lactobacillus rhamnosus LRa05 is derived from fecal samples of healthy infants and has received a GRAS (Generally Recognized as Safe) no-objection letter from the US FDA for use as a regular food ingredient. Its safety assessment includes genomic analysis, in vitro toxicology tests, animal toxicology experiments, and human studies. This study aims to evaluate the effects of LRa05 intervention on promoting the growth and development of healthy infants and toddlers of different ages, enhancing their immune function, and reducing the incidence of common diseases, as well as to analyze the safety of LRa05 and its impact on the intestinal microbiota.
Who can participate?
Healthy infants and toddlers aged 0-3 years, born at full term (37-42 weeks of gestation) with a birth weight of at least 2500g but less than 4000g with an allergy risk score ≥ 6 points (high degree of sensitization)
What does the study involve?
This study is a prospective, multicenter, placebo-controlled, double-blind clinical trial. The study is divided into three randomly allocated groups:
1. Probiotic intervention group: once daily, one packet (containing 1×10¹⁰ CFU of LRa05 per packet)
2. Placebo control group: once daily, one packet (maltodextrin, without LRa05)
3. Breastfeeding control group: no intervention measures, only breastfed
The main observation indicators include:
- Incidence of infant eczema (primary indicator)
- Growth and development (changes in weight, height, and head circumference)
- Incidence of other allergic diseases, gastrointestinal and respiratory tract infections
- Changes in intestinal microbiota diversity and abundance
- Safety indicators (adverse event records)
What are the possible benefits and risks of participating??
Potential Benefits:
- May promote the growth and development of infants and toddlers
- May enhance immune function and reduce the incidence of allergies
- May improve intestinal health
Potential Risks:
- Possible adverse events such as nausea, vomiting, dizziness, and drowsiness
- Adverse events and serious adverse events will be closely monitored during the study period, and the incidence, occurrence time, and severity of all adverse events will be recorded
Where is the study run from?
The Baoxing County Center for Disease Control and Prevention, China
When is the study starting and how long is it expected to run for?
June 2025 to December 2027. The study enrolment period is from January 2026 to December 2026. Each participant's intervention period is 3 months, followed by a 3-month follow-up period.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Chen Ke (Principal Investigator), kechen@uestc.edu.cn
Contact information
Public, Scientific, Principal investigator
1617 Riyue Avenue, Qingyang District
Chengdu, Sichuan
610072
China
 ORCID ID |
0000-0001-7455-0900 |
|---|---|
| Phone | +86 13981782973 |
| kechen@uestc.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized blinded placebo-controlled clinical study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 48429_PIS.pdf |
| Scientific title | A prospective, randomized, blinded, placebo-controlled clinical study on the effects of Lactobacillus rhamnosus LRa05 intervention on growth and development, allergic disease incidence, and immune function in infants and young children |
| Study acronym | Study about LRa05 |
| Study objectives | Evaluate the effects of LRa05 intervention in promoting the growth and development of healthy infants and young children of different age groups, enhancing their immune function, and reducing the incidence of common diseases. Analyze the safety of LRa05 and its impact on the intestinal microecology. |
| Ethics approval(s) |
Approved 20/09/2025, Ethics Committee of Baoxing County Center for Disease Control and Prevention (No.1 Zhongling Avenue, Baoxing County, Ya'an City, Sichuan Province, 625700, China; +86 0835-6822027; 41541194@qq.com), ref: Keyanlunshen 2025(01) |
| Health condition(s) or problem(s) studied | Promoting the growth and development of healthy infants and young children of different age groups, enhancing their immune function, and reducing the incidence of common diseases. |
| Intervention | This study is a randomized controlled blind intervention study. A random allocation table was generated by a biostatistician using statistical software on a computer. A total of 440 subjects were included, with 120 subjects in each of the 0-6 months, 6-12 months, and 12-36 months age groups. Additionally, an 80-subject breastfed control group for the 0-6 months age group was added. The random allocation table generated by the biostatistician was used for coding to meet the requirements of randomization. Subjects were enrolled strictly in the order of their random numbers and no changes were allowed. Each subject was randomly assigned to the probiotic intervention group, the placebo control group, or the breastfed control group. The groups were divided as follows: 1) Probiotic intervention group: One packet per day (containing 1×1010 CFU of LRa05 strain per packet), starting from the day of using the probiotic product and continuing for 3 months, followed by a 3-month follow-up. 2) Placebo control group: One packet per day (containing maltodextrin, without LRa05 strain), starting from the day of using the placebo product and continuing for 3 months, followed by a 3-month follow-up. 3) Breastfed control group: No intervention measures were taken, only breastfed. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Incidence of allergy in infants measured using clinical data at 3 and 6 months during the whole study |
| Key secondary outcome measure(s) |
1. Intestinal health status of infants (occurrence of functional gastrointestinal diseases such as diarrhea and constipation, and functional dyspepsia syndrome) measured using clinical data at 3 and 6 months during the whole study |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 0 Months |
| Upper age limit | 3 Years |
| Sex | All |
| Target sample size at registration | 440 |
| Key inclusion criteria | Exclusive breastfeeding group: 1. Healthy infants and toddlers born at term (37-42 weeks of gestation) who are exclusively breastfed, with a birth weight of at least 2500g but less than 4000g, and no gender restrictions 2. The mother has no diagnosed metabolic diseases, such as diabetes, and no infectious diseases, such as hepatitis B or HIV 3. The age at inclusion is less than 7 months 4. The allergy risk score calculated using the "Infant and Toddler Allergy Risk Assessment Form" is ≥ 6 points (refer to the "Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Toddlers" by the Maternal and Child Health Center of the Chinese Center for Disease Control and Prevention) 5. The parents or main guardians of the infants and toddlers agree to collect fecal samples from the infants and toddlers during the study period 6. There are no diagnosed allergic diseases by a clinical physician at the time of inclusion (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) 7. The infants and toddlers have established a health record at the local maternal and child health hospital's pediatric health department and receive regular physical examinations and feeding advice and guidance from pediatric health doctors 8. The family members or main guardians promise not to add any additional probiotic products (including formula milk powder containing probiotics) to the infants and toddlers during the study period 9. The guardians of the included subjects agree to participate in this interventional study and sign a written informed consent form and are able to understand and fill out the infant and toddler diaries and other forms as required Formula feeding group: 1. Healthy infants and toddlers born at term (37-42 weeks of gestation) who are formula-fed, with a birth weight of at least 2500g but less than 4000g, and no gender restrictions 2. The mother has no diagnosed metabolic diseases, such as diabetes, and no infectious diseases, such as hepatitis B or HIV 3. The age at inclusion is 0-6 months, 7-12 months, or 13-36 months 4. The allergy risk score calculated using the "Infant and Toddler Allergy Risk Assessment Form" is ≥ 6 points (refer to the "Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Toddlers" by the Maternal and Child Health Center of the Chinese Center for Disease Control and Prevention) 5. The parents or main guardians of the infants and toddlers agree to collect fecal samples from the infants and toddlers during the study period 6. There are no diagnosed allergic diseases by a clinical physician at the time of inclusion (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) 7. The infants and toddlers have established a health record at the local maternal and child health hospital's pediatric health department and receive regular physical examinations and feeding advice and guidance from pediatric health doctors 8. The family members or main guardians promise not to add any additional probiotic products (including formula milk powder containing probiotics) to the infants and toddlers during the study period 9. The guardians of the included subjects agree to participate in this interventional study and sign a written informed consent form and are able to understand and fill out the infant and toddler diaries and other forms as required |
| Key exclusion criteria | Exclusive breastfeeding control group: 1. Infants and young children with a history of asphyxia at birth or a history of NICU hospitalization 2. Infants and young children with birth defects or congenital abnormalities 3. Infants and young children whose mothers had high-risk obstetric factors during pregnancy, such as pregnancy-induced hypertension syndrome, preeclampsia and eclampsia, gestational diabetes, and cholestasis of pregnancy, as well as a history of alcohol abuse or drug abuse 4. Infants and young children who had used antibiotics within two weeks before enrollment 5. Infants and young children who had diseases that definitely affected growth and development within one month before enrollment (such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, etc., severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as definite genetic metabolic diseases, chromosomal diseases, and genetic diseases) 6. Infants and young children with severe primary diseases of important organs or systems such as the heart, liver, kidneys, and hematopoietic system 7. Infants and young children who had used any experimental drugs or participated in other clinical studies within three months before screening (for infants and young children under 3 months of age, the time from birth to enrollment is calculated) 8. Infants and young children who had taken probiotic products within one month before enrollment (for infants and young children under 1 month of age, the time from birth to enrollment is calculated) 9. Infants and young children who had used drugs that suppressed immune function (such as glucocorticoids and immunosuppressants) before enrollment 10. Infants and young children who were allergic to the known components of the probiotic product 11. Children with malnutrition requiring hospitalization 12. Other reasons considered by the researcher as unsuitable for participation in this clinical trial, such as those that affect the evaluation of efficacy or have poor compliance Healthy infants and young children aged 0-6 months: 1. Infants and young children with a history of asphyxia at birth or a history of NICU hospitalization 2. Infants and young children with birth defects or congenital abnormalities 3. Infants and young children whose mothers had high-risk obstetric factors during pregnancy, such as pregnancy-induced hypertension syndrome, preeclampsia and eclampsia, gestational diabetes, and intrahepatic cholestasis of pregnancy, as well as a history of alcohol abuse or drug abuse 4. Infants and young children who had used antibiotics within 2 weeks before enrollment 5. Infants and young children who had diseases that definitely affected growth and development within 1 month before enrollment (such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, etc., severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as definite genetic metabolic diseases, chromosomal diseases, and genetic diseases) 6. Infants and young children with severe primary diseases of important organs or systems such as the heart, liver, kidneys, and hematopoietic system 7. Infants and young children who had used experimental drugs after birth or participated in other clinical studies before screening 8. Infants and young children who had taken probiotic products within 1 month before enrollment (for infants younger than 1 month, the time from birth to enrollment is calculated) 9. Infants and young children who had used drugs that inhibit immune function (such as glucocorticoids and immunosuppressants) before enrollment 10. Infants and young children who are allergic to known components of probiotic products 11. Children with malnutrition requiring hospitalization 12. Other reasons considered by the researcher as unsuitable for participation in this clinical trial, such as those that affect the evaluation of therapeutic effect or have poor compliance Healthy infants and toddlers aged 7 to 12 months: 1. Infants and toddlers who have used antibiotics within 2 weeks before enrollment 2. Infants and toddlers with definite diseases that affect growth and development within 1 month before enrollment (such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, etc., severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as definite genetic metabolic diseases, chromosomal diseases, genetic diseases, etc.) 3. Infants and toddlers with severe primary diseases of other important organs or systems such as heart, liver, kidney, and hematopoietic system 4. Infants and toddlers who have used any experimental drugs or participated in other clinical studies within 3 months before screening 5. Infants and toddlers who have taken probiotic products within 1 month before enrollment 6. Infants and toddlers who have used drugs that inhibit immune function (such as glucocorticoids, immunosuppressants) before enrollment 7. Infants and toddlers who are allergic to the known components of probiotic products 8. Children with malnutrition requiring hospitalization 9. Other reasons considered by the researcher as unsuitable for participation in this clinical trial, such as those that affect the evaluation of therapeutic effect or have poor compliance Healthy infants and toddlers aged 13 to 36 months: 1. Infants and toddlers who have used antibiotics within 2 weeks before enrollment 2. Infants and toddlers who have had diseases that definitely affect growth and development within 1 month before enrollment (such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, etc., severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as definite genetic metabolic diseases, chromosomal diseases, genetic diseases, etc.) 3. Infants and toddlers with severe primary diseases of other important organs or systems such as the heart, liver, kidneys, and hematopoietic system 4. Infants and toddlers who have used any experimental drugs or participated in other clinical studies within 3 months before screening 5. Infants and toddlers who have taken probiotic products within 1 month before enrollment 6. Infants and toddlers who have used drugs that inhibit immune function (such as glucocorticoids, immunosuppressants) before enrollment 7. Infants and toddlers who are allergic to the known components of probiotic products 8. Children with malnutrition requiring hospitalization 9. Other reasons considered by the researcher as unsuitable for participation in this clinical trial, such as those that affect the evaluation of efficacy or have poor compliance |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- China
Study participating centre
Yaan
625700
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository, Clinical Trial Management Public platform://www.medresman.org.cn/login.aspx. Original data will be uploaded within 6 months after the end of the trial. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 11/11/2025 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | 11/11/2025 | No | No |
Additional files
- 48429_PIS.pdf
- Participant information sheet
- 48429_SAP.pdf
- Statistical Analysis Plan
Editorial Notes
07/11/2025: Study's existence confirmed by the Ethics Committee of Baoxing County Center for Disease Control and Prevention, China.
