Clinical Trials Logo
  1. Home
  2. Gut Microbiota
  3. NCT04991792

Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section — GOLF-CS  

Gut Microbiota Clinical Trial

Official title:
Evaluation of the Effect of an Infant Formula Containing Synbiotics on the Composition of the Gut Microbiota in Infants Born Via Caesarean Section

Clinical Trial 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.

Clinical Trial Description

Since caesarean section (CS)-born infants show dysbiotic microbial colonization during the first weeks of life, exclusive breastfeeding is the feeding mode of choice for these infants. However, since CS births are often associated with breast-feeding difficulties, it is of importance to feed an microbiota-supportive infant formula. This study is designed to investigate whether an infant formula supplemented with synbiotics positively affects the microbial composition, gastrointestinal characteristics and the proper function of the immune system in CS-born infants, compared to feeding a standard infant formula without synbiotics in either CS- and vaginal-born infants during the first 6 months of life. The growth of the infants as well as tolerance, infectious diseases and allergies will also be assessed. In order to investigate the effect of different birth modes and feeding conditions on the microbiota, the study population will include healthy term infants, born either by CS or by VD, additional groups receive human milk or formula with prebiotics only. Additionally, if the parents agree, their infant will be followed up until 24 months of age with a special focus on the prevention of infections and allergies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04991792
Study type Interventional
Source HiPP GmbH & Co. Vertrieb KG
Contact
Status Active, not recruiting
Phase N/A
Start date September 23, 2021
Completion date July 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02151825 - Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects N/A
Completed NCT01545219 - A Study of a Prebiotic, a Probiotic and a Synbiotic Upon the Gut Microbiota and Immune Response of Healthy Volunteers N/A
Active, not recruiting NCT04435548 - Westlake Gut Microbiome Study
Enrolling by invitation NCT05057039 - The Study of Gut Microbiota in Hypertensive Patients
Not yet recruiting NCT05039060 - Modified MAC Diet and Gut Microbiota in CRC Patients N/A
Completed NCT03746158 - Interindividual Variation in Excretion of Curcumin N/A
Active, not recruiting NCT03266055 - Effects of Blueberry on Gut Microbiota and Metabolic Syndrome N/A
Completed NCT04960878 - The Effect of Synbiotics on the Upper Respiratory Tract Infection N/A
Active, not recruiting NCT05607745 - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study N/A
Recruiting NCT04120051 - The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults N/A
Not yet recruiting NCT05481866 - Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum N/A
Completed NCT03293693 - Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects N/A
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Recruiting NCT04203459 - The Mechanism of Enhancing the Anti-tumor Effects of CAR-T on PC by Gut Microbiota Regulation
Active, not recruiting NCT03259685 - Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome N/A
Recruiting NCT06157346 - Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
Completed NCT03203044 - Impact of Soylent Consumption on Human Microbiome Composition N/A
Recruiting NCT05975541 - Susceptibility to Infectious Diseases in Obesity
Active, not recruiting NCT05457439 - Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment N/A
Recruiting NCT05065515 - Establishment of Individualized Immunotherapy Strategy and Platform Based on Changes of Intestinal Microbiota