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Trial record 10 of 29 for:    GUSB

The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia

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ClinicalTrials.gov Identifier: NCT03876678
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ming-Luen Tsai, China Medical University Hospital

Brief Summary:
This trial will be carried out in two stages in the sick baby room of the Children's Hospital of China Medical University (CMUH). The first stage is: the enzyme active reaction kit (usually called API ZYM kit) was used to determine the β-glucuronidase activity of 9 strains of Lactobacillus and 4 strains of Bifidobacterium, screening out the probiotics that have the best inhibitory efficacy of intestinal β-glucuronidase activity; The second stage is: using the results of the first stage analysis, treating the newborns of jaundice by oral probiotics.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia, Neonatal Other: Lactobacillus Salivarius AP-32 Other: Bifidobacterium Animalis subspecies Lactis CP-9 Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: probiotic or placebo capsule
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
Experimental: Light therapy and oral L. salivarius AP-32
Light therapy and taking 1 L. salivarius AP-32 probiotic capsule two times everyday for 7 days.
Other: Lactobacillus Salivarius AP-32
Taking 1 probiotic capsule two times everyday for 7 days.

Experimental: Light therapy and oral B. Animalis subsp. Lactis CP-9
Light therapy and taking 1 B. Animalis subsp. Lactis CP-9 probiotic capsule two times everyday for 7 days.
Other: Bifidobacterium Animalis subspecies Lactis CP-9
Taking 1 probiotic capsule two times everyday for 7 days.

Placebo Comparator: Light therapy and oral placebo
Light therapy and taking 1 placebo capsule two times everyday for 7 days.
Other: Placebo
Taking 1 placebo capsule two times everyday for 7 days.




Primary Outcome Measures :
  1. Serum bilirubin level [ Time Frame: 7 days. ]
    The study will be conducted for 7 days, the serum bilirubin level will be measured every day.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 7 days. ]
    All babies are monitored for adverse events such as vomiting, diarrhea or bloating.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Full-term infants (≧37 weeks).
  2. Jaundice index greater than 15 mg/dl on the fourth day after birth.

Exclusion Criteria:

  1. Hypothyroidism
  2. Trisomy 21
  3. Maternal blood type A, B and O incompatibility
  4. Gastrointestinal disease
  5. Glucose-6-Phosphate Dehydrogenase deficiency (G6PD deficiency)
  6. Hemangioma
  7. Cephalhaematoma or hemorrhages
  8. Severe asphyxia (stage III)
  9. Fetal chromosomal anomalies
  10. Cyanotic congenital heart disease
  11. Omphalocele
  12. Early onset sepsis
  13. Liver failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876678


Contacts
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Contact: Ming-luen Tsai 886-4-22052121 ext 4640 d23503@mail.cmuh.org.tw
Contact: Hung-chih Lin 886-4-22052121 ext 4640 d0373@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 40447
Contact: Ming-luen Tsai    886-4-22052121 ext 4640    d23503@mail.cmuh.org.tw   
Contact: Hung-chih Lin    886-4-22052121 ext 4640    d0373@mail.cmuh.org.tw   
Principal Investigator: Ming-luen Tsai         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Director: Hung-chih Lin China Medical University Hospital

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Responsible Party: Ming-Luen Tsai, Attending physician, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03876678     History of Changes
Other Study ID Numbers: CMUH107-REC1-136
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ming-Luen Tsai, China Medical University Hospital:
Hyperbilirubinemia
Jaundice
Probiotics
Intestinal microbial flora
Additional relevant MeSH terms:
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Hyperbilirubinemia, Neonatal
Hyperbilirubinemia
Pathologic Processes
Infant, Newborn, Diseases