Clinical trials: Synbiotics
Gut Microbiota
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
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…
- Trial name
- GOLF-CS (NCT04991792)
- Testing
- Intervention Group 1: Infant Formula with synbiotics, Intervention Group 2: Infant Formula with prebiotics, Control Group 1 and 2: Infant Formula without synbiotics
- Where
- Bulgaria
- Volunteers
- 486 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Infant Development
Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
The aim of this trial is to verify - based on metabolomics and other anthropometric parameters - whether exclusive nutrition of infant formula enriched with synbiotics (probiotics B.lactis and prebiotics FOS), Long-Chain…
- Trial name
- mtburnIFsynb (NCT03320837)
- Testing
- Infant formula, Breast milk
- Where
- Greece
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Rontis Hellas SA
Healthy Nutrition
A Follow-up Study of Dragon Study (NCT03520764): to Assess the Growth and Immune-related Outcomes
Dragon follow-up aims to evaluate the growth, allergies, and infections of Chinese subjects up to four years of age who completed the intervention period visit (from Day 0-44 to Week 17) of the Dragon study [EBB16SI08406].
- Trial name
- NCT05476289
- Testing
- No intervention
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Danone Nutricia
Healthy Full Term Infants
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
The primary objectives of this trial are: to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp.
- Trial name
- NCT02031887
- Testing
- formula with synbiotics, formula without synbiotics
- Where
- 3 sites in South Africa
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Formula
Supplementation of Infant Formula With Synbiotics
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
- Trial name
- NCT01625273
- Testing
- Lactobacillus paracasei paracasei strain F19
- Where
- Poland
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Arla Foods
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- TEMPO (NCT03067714)
- Testing
- Infant formula with added synbiotics, Standard infant formula
- Where
- 59 sites in Belgium, Czechia and 11 more
- Volunteers
- 855 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Healthy Term Infants
The Combiotic-Study
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in…
- Trial name
- GOLFIII (NCT02221687)
- Testing
- Synbiotic formula, Control formula
- Where
- 25 sites in France
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Infant Nutrition
Effects of a Synbiotics-containing Starter Formula on Infant Growth
In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics.
- Trial name
- NCT01010113
- Testing
- Standard infant formula with prebiotics, Infant formula with synbiotics
- Where
- Singapore
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Atopic Dermatitis (AD)
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy.
- Trial name
- SPHINX (NCT06943469)
- Testing
- Test formula, Control formula
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Acute Otitis Media
Bio-Kult Infantis® in AAD Prevention in Infants
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the intestinal mucosa associated to the administration of antibiotics.
- Trial name
- NCT03516409
- Testing
- Biokult
- Where
- Italy
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Probiotics International Ltd.
Constipation, Signs and Symptoms
Tolerability and Functional Assessment of a Novel Children's Synbiotic
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers…
- Conditions
- Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation
- Trial name
- PDS-08™ (NCT04534036)
- Testing
- PDS-08
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Seed Health
Gastrointestinal Tolerance of Probiotics in Infants
Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers
Background and Significance: Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be…
- Trial name
- NCT06746285
- Testing
- Synbiotic Supplement
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Iron Absorption
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect…
- Trial name
- NCT04774016
- Testing
- Test formula A without added pre- and pro-biotic, Test formula B with synbiotic, Test formula C with HMOs
- Where
- Thailand
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Gastro-intestinal Infections, Infections With Fever
Effect of Starter Formula on Infection Prevention
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
- Trial name
- NCT01880970
- Testing
- starter infant formula with pro and prebiotics
- Where
- 7 sites in France, Germany and 1 more
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Infants
Starter Infant Formula With Synbiotics
This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and…
- Trial name
- NCT06073652
- Testing
- Control 1st age starter infant formula, Experimental 1st age starter infant formula
- Where
- 3 sites in Philippines
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- MAESTRO (NCT03062995)
- Testing
- Infant Formula with added synbiotics, Standard Infant formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nutricia Research
Dietary Intervention
Growth of Infants Fed New Starter Formula
The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.
- Trial name
- NCT01079208
- Testing
- test starter infant formula, test starter infant formula with synbiotics, control standard formula
- Where
- 3 sites in United States
- Volunteers
- 297 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Febrile Neutropenia, Neutropenia
Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients
Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the main sources of infections during neutropenia.
- Conditions
- Febrile Neutropenia, Neutropenia, Infection in an Immunocompromised Host, Cancer
- Trial name
- FENSY (NCT02544685)
- Testing
- Probio-Fix Inum, Beneo Synergy 1
- Where
- Slovakia
- Volunteers
- 120 people
- Sponsor
- S&D Pharma SK s.r.o.
Follow-on Formula, Infant
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will…
- Conditions
- Follow-on Formula, Infant, Faeces, Gut Microbiota
- Trial name
- FUNTASTIC (NCT07207109)
- Testing
- Test: Follow-on formula with synbiotics, Control: Regular follow-on formula
- Where
- 2 sites in Indonesia
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Beneficial Bacteria in Gut
Color Synbiotics Study
This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.
- Trial name
- NCT01813175
- Testing
- Regular non-hydrolysed cow's milk I, Regular non-hydrolysed cow's milk II, Regular non-hydrolysed cow's milk - control
- Where
- 3 sites in Thailand
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.