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
Obesity
Effects of Synbiotics on Obesity
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty…
- Trial name
- NCT06578143
- Testing
- Synbiotics
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Leeuwenhoek Laboratories Co. Ltd.
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.
Vaginal Health
A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.
- Trial name
- NCT07435350
- Testing
- Vaginal Health Active VV-01
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Radicle Science
Antibiotic Side Effect, Antibiotic-associated Diarrhea
Metagenomic and Metabolomic Reconstitution of Gut Microbiota After Broad Spectrum Antibiotic Therapy
In the United States, healthcare providers prescribe over 270 million antibiotic prescriptions each year. While antibiotics have transformed medicine and methods of treating life-threatening bacterial infection, broad spectrum…
- Conditions
- Antibiotic Side Effect, Antibiotic-associated Diarrhea, Antibiotic-induced Dysbiosis, Antibiotic-induced Epithelial Barrier Disintegrity
- Trial name
- NCT04171466
- Testing
- Ciprofloxacin + Metronidazole, SH-DS01
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Seed Health
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 Microbiome (Focus), Gastrointestinal Symptoms
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults. The study includes an 8-week intervention period followed by a 2-week follow-up period.
- Trial name
- myBIOM (NCT07453823)
- Testing
- Synbiotic
- Where
- Ireland
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Chr Hansen - part of Novonesis
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)
Gastrointestinal, Gut Health
Consumer Health Study Aims to Evaluate the Safety, Tolerability and Impact of ED02 Probiotic Supplement on Gastrointestinal Outcomes
The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor.
- Trial name
- NCT07423897
- Testing
- Bifidobacterium pseudocatenulatum
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Synbiotic Health
Healthy Adult Participants, Gut Microbiomes
DORA - A Study Using Digital Health Tools/Platform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital…
- Conditions
- Healthy Adult Participants, Gut Microbiomes, AI
- Trial name
- DORA (NCT07575529)
- Testing
- Synbiotic Nutritional Product
- Where
- Singapore
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
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)