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
Severe Acute Malnutrition
Synbiotics for the Management of Malnutrition (Children)
In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting.
- Trial name
- NCT06722404
- Testing
- Standard therapeutic foods, Therapeutic foods plus Synbiotics
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
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)
End Stage Renal Disease (ESRD), Kidney Failure, Chronic
Probiotic and Synbiotic Supplements in Hemodialysis Patients
This single-center randomized controlled trial evaluated the effects of natural probiotic and synbiotic supplementation on clinical and biochemical characteristics in adults with end-stage renal disease receiving maintenance…
- Conditions
- End Stage Renal Disease (ESRD), Kidney Failure, Chronic, Hemodialysis
- Trial name
- NCT07531186
- Testing
- Natural Probiotic Supplement, Natural Synbiotic Supplement (Probiotic + Prebiotic Oat Fiber)
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Mansoura University
Obesity, Childhood, Obesity, Adolescent
PROBESITY-2: Synbiotics in Pediatric Obesity
The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviours, such as eating habits and daily physical activity…
- Trial name
- PROBESITY-2 (NCT05162209)
- Testing
- Synbiotic
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Eskisehir Osmangazi University
Cerebral Palsy (CP), Constipation
Effect of Probiotics on Constipation and Weight in CP
The goal of this clinical trial is to learn whether using Lactobacillus reuteri or a prebiotic-containing Lactobacillus rhamnosus supplement helps to improve constipation and weight gain in children with cerebral palsy (CP).
- Conditions
- Cerebral Palsy (CP), Constipation, Probiotic
- Trial name
- cerebral palsy (NCT07393256)
- Testing
- Lactobacillus Reuteri Oral Solution [BioGaia], Lactobacillus Rhamnosus, Prebiotic (inulin)
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Ordu University
Autism Spectrum Disorder, Anxiety
Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
The objective of this study is to conduct a open-label pilot study evaluating the feasibility, tolerability and preliminary efficacy of a 12-week course of synbiotic in improving anxiety symptoms in children with ASD.
- Trial name
- NCT06126185
- Testing
- 12-week course of synbiotic
- Where
- Hong Kong
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
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
Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity
SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%.
- Conditions
- Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity, Infant Nutrition Disorders, Gut Microbiota
- Trial name
- SMASH (NCT07342621)
- Where
- 13 sites in Spain
- Volunteers
- 41 people
- Sponsor
- Outcomes'10
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)
Childhood Obesity, Childhood Overweight
Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight
This study was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. This study aimed to evaluate the effect of consuming fermented milk products containing Lactobacillus casei strain Shirota…
- Trial name
- NCT05423015
- Testing
- Lactobacillus casei strain Shirota, Lactobacillus casei strain Shirota plus inulin, Lactobacillus casei strain Shirota plus fructans from A. salmiana
- Where
- Mexico
- Volunteers
- 37 people
- Sponsor
- Universidad Autonoma de San Luis Potosí
HIV, Infant Morbidity
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
Primary Objective: To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
- Conditions
- HIV, Infant Morbidity, Breast Feeding
- Trial name
- MIGH-T MO (NCT05282485)
- Testing
- Synbiotic, Maltodextrin
- Where
- South Africa
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Columbia University
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)
Congenital Heart Disease
Synbiotics in Infants With Cyanotic Congenital Heart Disease
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in…
- Trial name
- NCT01810978
- Testing
- Bifidobacterium lactis plus inulin, Maltodextrin
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Growth
The Growth and Development of Breast and Formula Fed Term Asian Infants
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia
- Trial name
- NCT01721512
- Testing
- Breastfeeding, Infant formula
- Where
- Indonesia
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Necrotizing Enterocolitis, Sepsis
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants…
- Trial name
- NCT01807858
- Testing
- Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Dr. Sami Ulus Children's Hospital