4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Impact of Infant Formula With Probiotics on Infants Health

The Impact of Infant Formula With Probiotics on Infants Health

Study Description
Brief Summary:
The trial will be divided into three groups, the experimental group: (I) probiotic A formula, (II) probiotic B formula; control group: (III) regular formula (Youluck infant formula). Inclusion criteria included: (1) the normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams and (2) subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents. Exclusion criteria included: infants with chronic diarrhea, hemangioma, cerebral hemorrhage, severe asphyxia (stage III), fetal chromosomal abnormalities, cyanotic congenital heart disease, intestinal hypoplasia or abnormal immune function after birth, liver failure, breastfeeding within two months after birth, taking other probiotic products within two weeks after birth, treatment with antibiotics during acute infection and diagnosis of allergies, gastroenteritis, respiratory infections will be excluded. The study will be conducted for half a year, 5 cans of Youluck infant formula are provided for each subject during the test period. The Youluck infant formula is sponsored free of charge by glac biotech Co., Ltd. During hospitalization, the infant will be feed by same group of experienced nurses and all infants will be monitored for adverse conditions such as vomiting, diarrhea or bloating every day.

Condition or disease Intervention/treatment Phase
Probiotics Infant Formula Infants Health Other: Probiotic A formula Other: Probiotic B formula Other: Regular formula Not Applicable

Show Show detailed description
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Infant Formula With Probiotics on Infants Health
Actual Study Start Date : February 11, 2020
Actual Primary Completion Date : June 16, 2020
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Probiotic A formula
Infant Formula with Lactobacillus salivarius AP-32.
Other: Probiotic A formula
Feeding baby two meals a day with Infant formula with probiotics (10^8 colony-forming unit per day) at least.

Experimental: Probiotic B formula
Infant Formula with Bifidobacterium lactis CP-9.
Other: Probiotic B formula
Feeding baby two meals a day with Infant formula with probiotics (10^8 colony-forming unit per day) at least.

Placebo Comparator: Regular formula
The infant formula without any probiotic.
Other: Regular formula
Feeding baby two meals a day with regular formula at least.

Outcome Measures
Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 6 month follow-up. ]
    All babies are monitored for adverse events such as vomiting, diarrhea or bloating.

  2. Change in body weight [ Time Frame: 6 month follow-up. ]
    The baby will record the body weight before taking infant formula. During the half-year trial period, the body weight will also be measured every 2 months.

  3. Change in body height [ Time Frame: 6 month follow-up. ]
    The baby will record the body height before taking infant formula. During the half-year trial period, the body height will also be measured every 2 months.

  4. Change in head circumference [ Time Frame: 6 month follow-up. ]
    The baby will record the head circumference before taking infant formula. During the half-year trial period, the head circumference will also be measured every 2 months.


Secondary Outcome Measures :
  1. The occurrence of inflammatory bowel diseases [ Time Frame: 6 month follow-up. ]
  2. The occurrence of allergic diseases [ Time Frame: 6 month follow-up. ]
  3. The occurrence of respiratory infection [ Time Frame: 6 month follow-up. ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams.
  2. Subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents.

Exclusion Criteria:

  1. Chronic diarrhea
  2. Hemangioma
  3. Cerebral hemorrhage
  4. Severe asphyxia (stage III)
  5. Fetal chromosomal abnormalities
  6. Cyanotic congenital heart disease
  7. Intestinal hypoplasia or abnormal immune function after birth.
  8. Liver failure
  9. Breastfeeding within two months after birth.
  10. Taking other probiotic products within two weeks after birth.
  11. Treatment with antibiotics during acute infection and diagnosis of allergies.
  12. Gastroenteritis
  13. Respiratory infections
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hung-Chih Lin 886-4-22052121 ext 4640 d0373@mail.cmuh.org.tw

Locations
Layout table for location information
Taiwan
Department of Pediatrics, Children Hospital, China Medical University Recruiting
Taichung, Taiwan, 404
Contact: Hung-chih Lin    886-4-22052121 ext 4640    d0373@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Glac Biotech Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: Hung-Chih Lin China Medical University Hospital
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE February 11, 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Incidence of treatment-emergent adverse events [ Time Frame: 6 month follow-up. ]
    All babies are monitored for adverse events such as vomiting, diarrhea or bloating.
  • Change in body weight [ Time Frame: 6 month follow-up. ]
    The baby will record the body weight before taking infant formula. During the half-year trial period, the body weight will also be measured every 2 months.
  • Change in body height [ Time Frame: 6 month follow-up. ]
    The baby will record the body height before taking infant formula. During the half-year trial period, the body height will also be measured every 2 months.
  • Change in head circumference [ Time Frame: 6 month follow-up. ]
    The baby will record the head circumference before taking infant formula. During the half-year trial period, the head circumference will also be measured every 2 months.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Change in body weight [ Time Frame: 6 month follow-up. ]
    The baby will record the body weight before taking infant formula. During the half-year trial period, the body weight will also be measured every 2 months.
  • Change in body height [ Time Frame: 6 month follow-up. ]
    The baby will record the body height before taking infant formula. During the half-year trial period, the body height will also be measured every 2 months.
  • Change in head circumference [ Time Frame: 6 month follow-up. ]
    The baby will record the head circumference before taking infant formula. During the half-year trial period, the head circumference will also be measured every 2 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • The occurrence of inflammatory bowel diseases [ Time Frame: 6 month follow-up. ]
  • The occurrence of allergic diseases [ Time Frame: 6 month follow-up. ]
  • The occurrence of respiratory infection [ Time Frame: 6 month follow-up. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Infant Formula With Probiotics on Infants Health
Official Title  ICMJE The Impact of Infant Formula With Probiotics on Infants Health
Brief Summary The trial will be divided into three groups, the experimental group: (I) probiotic A formula, (II) probiotic B formula; control group: (III) regular formula (Youluck infant formula). Inclusion criteria included: (1) the normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams and (2) subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents. Exclusion criteria included: infants with chronic diarrhea, hemangioma, cerebral hemorrhage, severe asphyxia (stage III), fetal chromosomal abnormalities, cyanotic congenital heart disease, intestinal hypoplasia or abnormal immune function after birth, liver failure, breastfeeding within two months after birth, taking other probiotic products within two weeks after birth, treatment with antibiotics during acute infection and diagnosis of allergies, gastroenteritis, respiratory infections will be excluded. The study will be conducted for half a year, 5 cans of Youluck infant formula are provided for each subject during the test period. The Youluck infant formula is sponsored free of charge by glac biotech Co., Ltd. During hospitalization, the infant will be feed by same group of experienced nurses and all infants will be monitored for adverse conditions such as vomiting, diarrhea or bloating every day.
Detailed Description

Probiotics were defined as an ''live microorganisms, which, when administered in adequate amounts, conferred a health benefit on the host. Before 2005, some animal experiments indicated that probiotics could help weight gain. In 2006, there was a team observed the growth of infants who received infant formula with probiotics. The study found that infants who received infant formula with probiotics for half a year had higher height and weight than infants who received regular formula, and the defecation frequency was increased. So far, clinical studies had proved that probiotics had an efficacy on gastrointestinal immune regulation. Some studies had found that concentrated preparations mixed with various probiotics had therapeutic effects on inflammatory bowel diseases. The latest double-blind study of infants with acute diarrhoea showed that oral dehydration supplements enriched probiotics and zinc could reduce the severity of diarrhoea on day 2 without any side effects. Therefore, more and more probiotic clinical studies had suggested that probiotics could be used to regulate gastrointestinal related diseases.

According to statistics, the proportion of atopic dermatitis in infants and children worldwide is about 10-20%, and about 30% of toddlers with more than three episodes of wheezing bronchitis may develop persistent asthma. Therefore, how to effectively prevent the occurrence of allergic diseases was still an urgent goal for infants and young children. There is now evidence in mice and humans of an early-life "critical window" in which the effects of gut microbial dysbiosis are most influential in human immune development. Investigators showed that infants at risk of asthma exhibited transient gut microbial dysbiosis during the first 100 days of life. Inoculation of the relatively lower abundance of the genus to asthmatic mice ameliorated airway inflammation. These results enhanced the potential for future microbe-based diagnostics and therapies, potentially in the form of probiotics, to prevent the development of asthma and other related allergic diseases in children.

In addition, respiratory infections were diseases that needed attention during the growth phase of infants and young children. The most common treatment for respiratory infections or acute otitis media in infants and young children was using antibiotics, but antibiotic treatment might lead to antibiotic resistance and intestinal microbial disorders, which might promote colonization of pathogens. In recent years, probiotics had attracted more and more attention for the prevention of respiratory infections. For example, investigators showed that using Bifidobacterium probiotics in children before 2 years old might reduce the incidence of respiratory infections.

Based on the above studies, Investigators will use infant formula with probiotics to infants. The study will assess the growth, incidence of allergies, gastroenteritis and respiratory infections of infants. This observational study will be conducted at the China Medical University Children's Hospital performed a double-blind randomized trial.

The trial will be divided into three groups, the experimental group: (I) probiotic A formula, (II) probiotic B formula; control group: (III) regular formula (Youluck infant formula). Inclusion criteria included: (1) the normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams and (2) subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents. Exclusion criteria included: infants with chronic diarrhea, hemangioma, cerebral hemorrhage, severe asphyxia (stage III), fetal chromosomal abnormalities, cyanotic congenital heart disease, intestinal hypoplasia or abnormal immune function after birth, liver failure, breastfeeding within two months after birth, taking other probiotic products within two weeks after birth, treatment with antibiotics during acute infection and diagnosis of allergies, gastroenteritis, respiratory infections will be excluded. The study will be conducted for half a year, 5 cans of Youluck infant formula are provided for each subject during the test period. The Youluck infant formula is sponsored free of charge by glac biotech Co., Ltd. During hospitalization, the infant will be feed by same group of experienced nurses and all infants will be monitored for adverse conditions such as vomiting, diarrhea or bloating every day. After the study is completed, the remaining probiotic milk powder will be subjected to high temperature and high pressure for sterilization, and then placed in an infectious garbage bag or infective trash can, and destructed by a cleaning company.

Sample size calculation is based on the literature. The incidence of enteritis, allergic disease or respiratory infection in infants is about 30%. Investigators assume that the experimental group has a 50% improvement compared with the control group. If investigators allow 5% chance of type 1 error (α=0.05) and 10% chance of type 2 error (β=0.1), then the required sample size in each group will be 60 people (total 180 infants in three groups).

The research data will be based on International Business Machines Statistical Product and Service Solutions (IBM SPSS) for analytical statistics. Normally distributed data were analyzed using Student's t-test two-tailed assay, and non-normally distributed data were analyzed using the Wilcoxon signed-rank test. Data were presented as mean ± standard deviation (SEM) or median, with P values < 0.05 being considered statistically significant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Probiotics Infant Formula
  • Infants Health
Intervention  ICMJE
  • Other: Probiotic A formula
    Feeding baby two meals a day with Infant formula with probiotics (10^8 colony-forming unit per day) at least.
  • Other: Probiotic B formula
    Feeding baby two meals a day with Infant formula with probiotics (10^8 colony-forming unit per day) at least.
  • Other: Regular formula
    Feeding baby two meals a day with regular formula at least.
Study Arms  ICMJE
  • Experimental: Probiotic A formula
    Infant Formula with Lactobacillus salivarius AP-32.
    Intervention: Other: Probiotic A formula
  • Experimental: Probiotic B formula
    Infant Formula with Bifidobacterium lactis CP-9.
    Intervention: Other: Probiotic B formula
  • Placebo Comparator: Regular formula
    The infant formula without any probiotic.
    Intervention: Other: Regular formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The normal spontaneous delivery (NSD) full-term health infants (≧37 weeks) and birth weight more than 2500 grams.
  2. Subjects who are expected to breastfeed are eligible for the trial after informed consent form is signed by the parents.

Exclusion Criteria:

  1. Chronic diarrhea
  2. Hemangioma
  3. Cerebral hemorrhage
  4. Severe asphyxia (stage III)
  5. Fetal chromosomal abnormalities
  6. Cyanotic congenital heart disease
  7. Intestinal hypoplasia or abnormal immune function after birth.
  8. Liver failure
  9. Breastfeeding within two months after birth.
  10. Taking other probiotic products within two weeks after birth.
  11. Treatment with antibiotics during acute infection and diagnosis of allergies.
  12. Gastroenteritis
  13. Respiratory infections
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Hung-Chih Lin 886-4-22052121 ext 4640 d0373@mail.cmuh.org.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993301
Other Study ID Numbers  ICMJE CMUH108-REC2-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hung-Chih Lin, China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Glac Biotech Co., Ltd
Investigators  ICMJE
Principal Investigator: Hung-Chih Lin China Medical University Hospital
PRS Account China Medical University Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院