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Randomized controlled study of the effects of Lacticaseibacillus paracasei 207-27 on the health of infants and toddlers aged 7-36 months

Randomized controlled study of the effects of Lacticaseibacillus paracasei 207-27 on the health of infants and toddlers aged 7-36 months

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089873
Enrollment
Unknown
Registered
2024-09-18
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysbacteriosis

Interventions

Intervention group:Take 1 bag of powder containing Lacticaseibacillus paracasei 207-27 daily, 1g per bag, with each bag containing Lacticaseibacillus paracasei 207-27 =1×10^10 CFU/g
mix with plain water or milk at a temperature not exceeding 40oC.
Control group:Take one bag of placebo (pure maltodextrin) with the same packaging daily, 1g per bag, using the same method of administration.

Sponsors

Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1. Healthy infants aged 7-36 months delivered at full term meet the standards for healthy infants of their age group, and their parents can understand the requirements of the agreement and complete the baby diary as required; 2. Healthy, singleton or twin, gestational age >= 37 weeks (who), birth weight >= 2500 g, current weight is between P20 and p80 according to the percentage map of the weight of children aged 0-18; 3. The intervention group and the control group were infants fed with mixed feeding or artificial feeding; 4. Parents agree to take the recommended probiotics; 5. The infant formula does not contain probiotics, and can only contain galactooligosaccharide (GOS) < 2G/100g as prebiotics without fructooligosaccharides.

Exclusion criteria

Exclusion criteria: 1. Congenital disease or deformity; Severe prenatal and post natal diseases; Mothers with metabolic and / or chronic diseases; Probiotic allergy constitution; Infants with serious diseases, such as cardiovascular diseases, cerebrovascular, endocrine, liver, kidney and hematopoietic system or mental diseases; 2. Ingestion of other drugs that may affect the effect during the study, resulting in failure to judge the efficacy of probiotics and/or affect the judgment of results; 3. Current or past diseases, conditions, or interventions that may interfere with the study (affecting tolerance and/or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndrome, malnutrition, congenital immune deficiencies, or major surgeries; 4. Oral antibiotics or other medications or nutritional supplements containing probiotics and prebiotics (excluding infant formula) taken within 2 weeks before the intervention; 5. Special medical purpose foods in the form of non-standard formula powders, used for lactose intolerance and galactosemia; 6. Infants with potential food allergies, such as allergies to milk, soy protein, fish protein, or egg protein; 7. Participation in or having participated in other clinical studies within the 4 weeks prior to the intervention; 8. The legal guardian of the baby has mental or mental illness and does not have the language ability to sign the informed consent form; 9. The investigator can judge the reason why the infant's parents cannot meet the requirements of the study record (such as being unable to contact the investigator in an emergency, or suffering from drug and alcohol addiction).

Design outcomes

Primary

MeasureTime frame
Intestinal flora;sIgA;Weight;Height;Head circumference;

Countries

China

Contacts

Public ContactYumei Zhang

Department of Nutrition and Food Hygiene, School of Public Health, Peking University

zhangyumei@bjmu.edu.cn+86 134 2613 4251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026