Clinical trials: Gastrointestinal Microbiota
Functional Dyspepsia
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause.
- Trial name
- SUBTILE (NCT07212907)
- Testing
- Symbiosys® Stomalex (commercial name)
- Where
- 2 sites in France
- Volunteers
- 198 people
- Sponsor
- Biocodex
Gut Microbiome
Effect of Fenugreek Fibre on Gut Microbiome
A open label, self-controlled trial to evaluate the effect of Fenugreek Fibre (Trigonella foenum-graecum) on the gut microbiome in generally healthy adults aged 18-65 years old.
- Trial name
- NCT06006416
- Testing
- Fenugreek Fibre
- Sponsor
- RDC Clinical Pty Ltd
Obesity & Overweight, Circadian Rhythm Disorders
Effects of Akkermansia Muciniphila and Berberine Supplementation on Insulin Sensitivity in Night-shift Workers
Night shift work is associated with an increased risk of obesity, insulin resistance, and cardiometabolic disorders, largely due to circadian misalignment, disrupted sleep, and altered eating patterns.
- Conditions
- Obesity & Overweight, Circadian Rhythm Disorders, Gut Microbiota Modulation, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Trial name
- Shift2Health (NCT07440147)
- Testing
- Verum (A)
- Where
- Austria
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- FH Joanneum Gesellschaft mbH
Stress
BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.
- Trial name
- BALANCE (NCT07477470)
- Testing
- Prebiotic fibre blend
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- Myota GmbH
Focus of the Study is on Gut Health
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods.
- Trial name
- NCT01518088
- Testing
- Dietary Fiber
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ingredion Incorporated
Microbiota, Gut Microbiome
Flourish: Exploring the Early Infant Gut Microbiome
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months…
- Conditions
- Microbiota, Gut Microbiome, Eczema, Microbiome
- Trial name
- NCT07333482
- Testing
- Tailored Recommendations, Consult Call, Educational Email Series
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Seeding Inc
Crohn Disease
EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to…
- Trial name
- MAINTAIN (NCT05542355)
- Testing
- EXL01, SoC corticosteroid - Induction Period, SoC corticosteroid - Tapering
- Where
- 5 sites in Belgium, Poland
- Volunteers
- 8 people
- Sponsor
- Exeliom Biosciences
Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
Effect of Lactiplantibacillus Plantarum DAD-13 on Inflammatory Markers in ICU Sepsis Patients
This study investigated whether giving the probiotic Lactiplantibacillus plantarum DAD-13 to sepsis patients in the intensive care unit (ICU) could help reduce inflammation and improve bowel function.
- Conditions
- Sepsis, Systemic Inflammatory Response Syndrome (SIRS), Critical Illness
- Trial name
- LactoSepsis (NCT07072871)
- Testing
- Lactiplantibacillus plantarum DAD-13
- Where
- Indonesia
- Volunteers
- 32 people
- Sponsor
- PT Royal Medikalink Pharmalab
Metabolic Syndrome, Anxiety
PRebiotic Intervention for Metabolic and MEntal Health (PRIME)
The purpose of the study is to determine whether a daily prebiotic fibre blend can reduce systemic inflammation, dyslipidemia, and self-report measures of mental health in individuals with metabolic syndrome.
- Conditions
- Metabolic Syndrome, Anxiety, Mood, Stress
- Trial name
- PRIME (NCT06216626)
- Testing
- myota's prebiotic fibre blend
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Myota GmbH
Healthy Volunteer
Calorie Restriction Intervention Induces Enterotype-associated BMI Loss in Nonobese Individuals
Calorie restriction (CR), which has the potential effect on weight loss and blood amino acids, has been demonstrated to associate with gut microbiota in humans, especially in obese individuals.
- Trial name
- CRDI (NCT04044118)
- Testing
- Low Calorie Diet
- Where
- China
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- BGI-Shenzhen
Tolerance, Healthy Population
Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses.
- Trial name
- NCT05794100
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Cardiovascular Risk Factor
A Pilot Study to Investigate the Effect of Water-soluble Tomato Extract on TMAO
To determine the effect of 4 weeks daily consumption of Fruitflow on changes in plasma levels of fasting Trimethylamine N-oxide concentrations (TMAO)
- Trial name
- NCT04160481
- Testing
- FruitFlow
- Where
- Ireland
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Axial Spondyloarthritis
Microbiome and Axial Spondyloarthritis
The purpose of this interventional study is to identify the root cause(s) of AxSpA (Axial Spondyloarthritis) relapses, which are likely due to the combination of nutrition, gut microbiome activities, leaky gut, and human genes…
- Trial name
- NCT04713995
- Testing
- Dietary recommendations
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Viome
Allergic Rhinitis (AR)
Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis
This clinical trial aims to evaluate the efficacy and safety of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis symptoms and its effects on gut microbiota in 70 adults aged 18-60 years.
- Trial name
- NCT06699537
- Testing
- probiotic product, Maltodextrin
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Wecare Probiotics Co., Ltd.
Glucose Metabolism Disorders, Health Behavior
Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects
When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut.
- Conditions
- Glucose Metabolism Disorders, Health Behavior, Diabetes, Metabolic Disease
- Trial name
- NCT06051318
- Testing
- Standardized breakfast A, Standardized breakfast B
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- BiomeHub Biotechnology Company
Healthy
ButyraGen™, Short Chain Fatty Acids and Gut Microbiome
This study is being conducted to demonstrate short chain fatty acid (SCFA), specifically butyrate, generation in stool, blood and urine in response to oral intake of ButyraGen™.
- Trial name
- BG (NCT05601635)
- Testing
- ButyraGen™
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Anxiety Depression
Probiotics Regulate Intestinal Health and Alleviate Anxiety
This study is a randomized, double-blind, placebo-controlled trial aimed primarily at investigating the effects of Weizmannia coagulans BC99 on alleviating anxiety and depression and the gut microbiota.
- Trial name
- NCT07353320
- Testing
- probiotics group
- Where
- China
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Wecare Probiotics Co., Ltd.
Diabetes Mellitus, Type 2, Obesity
Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
In recent years, the global rise in obesity and type 2 diabetes has become a major public health issue. In New Caledonia, 38% of the adult population has a body mass index ≥30.
- Trial name
- MIND (NCT07205913)
- Testing
- 25 ml blood sample, Urine sample, Stools
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Formula Milk, Infants
Infant Formula Study With Pre- And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula…
- Trial name
- NCT07734532
- Testing
- Infant Formula
- Where
- Ireland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nutricia UK Ltd
Kefir Usual Consumers and New Kefir Consumers
Activia Kefir Consumption in Real-world Setting
The study aims at generating first real-world insights into how consumers perceive the benefits of consuming Activia Kefir on their digestive wellbeing, overall wellbeing, and to explore its potential effects on the gut…
- Trial name
- KefirSelf (NCT07790666)
- Testing
- Commercialized dairy product consumption and stool samples collection
- Where
- 3 sites in Spain
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center