NCT06449508

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 1, 2024

Last Update Submit

June 7, 2024

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

  • the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.

    up to 4 weeks

Secondary Outcomes (1)

  • The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)

    up to 4weeks

Study Arms (2)

control

NO INTERVENTION

no intervention

probiotics

ACTIVE COMPARATOR

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

Interventions

Probiotic FormulaDRUG

drops of probiotic supplement containing bacillus clausil spores (Enterogermania Amp 2 Billion/5Ml )

Also known as: lactobacillus
probiotics

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg/dl and need phototherapy.

You may not qualify if:

  • neonates who have kernicterus.
  • neonates who have ventilation problem.
  • neonates who have heart failure.
  • neonates who have asphyxia.
  • neonates who have history of Rh incompatibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 10, 2024

Study Start

July 1, 2024

Primary Completion

June 20, 2025

Study Completion

July 1, 2025

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share