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Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section

NCT04991792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2025-05-06

No results posted yet for this study

Summary

A multi-centre, randomized, parallel-group, double-blind, controlled, exploratory clinical trial is conducted to assess the positive effect of feeding a formula containing synbiotics (pre- and probiotics) on the composition of the gut microbiota in caesarean section (CS) born healthy term infants within the first 6 months of life.

Conditions

  • Gut Microbiota

Interventions

OTHER

Intervention Group 1: Infant Formula with synbiotics

Infants will receive infant formula during the first 6 months of life

OTHER

Intervention Group 2: Infant Formula with prebiotics

Infants will receive infant formula during the first 6 months of life

OTHER

Control Group 1 and 2: Infant Formula without synbiotics

Infants will receive infant formula during the first 6 months of life

Sponsors & Collaborators

  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD, Pleven, Bulgaria

    collaborator UNKNOWN

  • HiPP GmbH & Co. Vertrieb KG

    lead INDUSTRY

Principal Investigators

  • Victoria Assoc. Prof. Dr. Atanasova, MD, PhD · "Dr. Georgi Stranski" EAD, 91 "Vladimir Vazov" Str., 5809 Pleven, Bulgaria

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
6 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2022-11-29
Completion
2024-07-07

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04991792 on ClinicalTrials.gov