A Phase 1/2 interventional study of Probiotic Formula in Jaundice, Neonatal, sponsored by Tanta University. Not yet recruiting. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment
Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.
Neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. The percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%.
Phototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion.
Probiotics can also be used for the treatment of jaundice. The efficacy of probiotics depends on their ability to pass across the GIT and cause colonization in the intestinal lumen. Hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 44 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Tanta University is the lead sponsor of 1,012 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no intervention
will receive 5 drops of probiotic supplement containing Bacillus clausil spores (Enterogermania amp 2 billion/5 mL) once daily plus phototherapy till discharge.
Drug: Probiotic Formula
drops of probiotic supplement containing bacillus clausil spores (Enterogermania Amp 2 Billion/5Ml )
Also known as: lactobacillus
the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.
Time frame: up to 4 weeks
The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)
Time frame: up to 4weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Jun 2025, 11 months later.
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bifidobacterium animalis subsp. lactis