Clinical trials: Gut-brain Axis
Irritable Bowel Syndrome
Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome
Low fermentable oligo-, di- and monosaccharides and polyols (FODMAPs) diet is taken as a possible strategy to improve symptoms in IBS patients.
- Trial name
- FODMAPs (NCT04283487)
- Testing
- Fructans, Glucose, Saline
- Where
- Belgium
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Healthy, Irritable Bowel Syndrome
Effect of Serotonergic Stimulation on the Gut-brain Axis
Selective serotonin reuptake inhibitors increase the level of serotonin. This study will use functional magnetic resonance imaging to examine how subjects with, and without, irritable bowel syndrome patients respond to…
- Trial name
- NCT03920410
- Testing
- serotonergic stimulation, no serotonergic stimulation
- Where
- Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Örebro University, Sweden
Healthy Volunteers, Stress
Effects of Rifaximin on Gut Microbiota and Emotion
A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.
- Conditions
- Healthy Volunteers, Stress, Fear
- Trial name
- NCT05587036
- Testing
- Rifaximin
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
IgA Nephropathy (IgAN)
Exploring the Brain - Gut Microbiota - Kidney Interactive Damage Mechanisms Underlying Cognitive Decline in Patients With IgA Nephropathy Using Ultra-high Field Magnetic Resonance Imaging
IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide. Its progression is often accompanied by cognitive decline, manifesting as multi-dimensional cognitive deficits in areas such as memory, attention…
- Trial name
- NCT07617402
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tang-Du Hospital
Appetitive Behavior, Obesity
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates.
- Conditions
- Appetitive Behavior, Obesity, Diabetes Mellitus, Type 2
- Trial name
- NCT05349903
- Testing
- Rice flour, Alternanoligosaccharide 15, Inulin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Purdue University
Cancer Survivors, Healthy Participant
A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors
This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system)…
- Conditions
- Cancer Survivors, Healthy Participant, Elderly
- Trial name
- GIANTS-1 (NCT07363057)
- Testing
- GI-102 in combination with GIB-7
- Where
- 2 sites in Australia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GI Innovation, Inc.
Obsessive-Compulsive Disorder, Tic Disorder
Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis
This study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (OCD) through performing an integrated analysis of gut microbiota, serum metabolomics…
- Trial name
- NCT06754319
- Where
- China
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Shanghai Mental Health Center
Obesity, Metabolic Syndrome
Rutazyme Lemon Fermented Product Capsules for Metabolic Function in Adults With Obesity
This study evaluates whether a fruit- and vegetable-based fermented product (Rutazyme® lemon fermented product) taken as a capsule can improve metabolic health in adults with obesity.
- Trial name
- NCT07540949
- Testing
- Rutazyme® Lemon Fermented Product Capsule
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- National Taiwan Sport University
Depressive Disorder, Major, Depression
The Effect of Probiotic Supplementation on the Mental Status, Inflammation, and Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet
More and more evidence confirms the relationship between the gut-brain-microbiota axis and the symptoms of mood disorders. A potential pathway connecting the intestines and the brain in depression is inflammation.
- Trial name
- SANGUT (NCT03877393)
- Testing
- Probiotic supplementation + gluten-free diet, Probiotic supplementation + gluten-containing diet
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- Medical University of Lublin
Healthy Adults Reporting Recurrent Gastrointestinal Symptoms
A Real-world Study of Gastrointestinal Health and Mental Wellness in U.S. Adults Following 12 Weeks of Probiotic Supplementation.
This real-world study conducted in the U.S.A aims to understand how gastrointestinal (GI) symptoms and wellbeing, including mood, sleep, and eating behaviours, change over time in 300 adults who choose to take a probiotic dietary…
- Trial name
- NCT07849036
- Testing
- Probiotic
- Where
- United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Novonesis
Clinical High Risk for Psychosis, Ultra High Risk for Psychosis
Endocannabinoid Activity Remodulation for Psychosis Liability in Youth
Clinical High-Risk (CHR) for Psychosis is characterized by the occurrence of unusual stressful experiences (attenuated psychotic symptoms, APS), anxious symptoms, psychological distress, and substantial impairment of the…
- Conditions
- Clinical High Risk for Psychosis, Ultra High Risk for Psychosis, Attenuated Psychotic Symptoms
- Trial name
- EARLY (NCT06037993)
- Testing
- Ultra-micronized Palmitoylethanolamide (PEA)
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- University of Udine
Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
Brain-Gut-Microbiota Interaction in IBS
Are you what you eat? How can dietary components influence microbial composition of the gut and function of the peripheral and central nervous system? The gut and brain is linked through complex mechanisms of sensorimotor…
- Trial name
- NCT04296552
- Testing
- Dietary lowFODMAP intervention
- Where
- Norway
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Haukeland University Hospital
Cognitive Assessment, Psychological Function
Snacks and Brain Health
This project will investigate whether daily snack consumption can improve memory, mood, and overall brain function in people with cognitive impairment.
- Conditions
- Cognitive Assessment, Psychological Function, GI Health
- Trial name
- NCT07348406
- Testing
- Pecan snack, Pretzel snack
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Texas Tech University Health Sciences Center
Fragile X Syndrome
Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome
The primary objective of this clinical trial is to evaluate efficacy of probiotic mixture which contains Lactobacillus casei, Lactobacillus salivarius and Bifidobacterium breve, in children with Fragile X aged 3-18 years.
- Trial name
- NCT06279858
- Testing
- Probiotics
- Where
- Serbia
- Volunteers
- 15 people
- Sponsor
- Specila hospital for cerebral palsy and developmental neurology
Schizophrenia Therapeutics
Berberine Improving Cognitive Impairments in Schizophrenia
This study is a 12-week, randomized, blank-controlled, assessor-blinded trial. Eligible patients were randomized in a 1:1 ratio to receive either berberine hydrochloride or blank control as an add on to their stable antipsychotic…
- Trial name
- NCT07359209
- Testing
- Berberine
- Where
- China
- Volunteers
- 124 people
- Sponsor
- Tianjin Anding Hospital
Gut-brain Axis, Dietary Changes
The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms .
To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.
- Conditions
- Gut-brain Axis, Dietary Changes, Probiotics Supplement, Depression Symptoms
- Trial name
- NCT06639646
- Testing
- Probiotics supplements, Health diet
- Where
- Egypt
- Volunteers
- 76 people
- Sponsor
- Kasr El Aini Hospital
Functional Dyspepsia
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.
- Trial name
- CONVERGE (NCT06360900)
- Testing
- Sensory device, Skills Building, Health Education
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Spaulding Rehabilitation Hospital
Obesity & Overweight
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Glucagon-like peptide (GLP1) drugs have quickly become a standard treatment for the adults with obesity. These drugs target the appetite control center of the brain, which clows the rate of stomach emptying, and makes a person…
- Trial name
- GUT BOOST (NCT07823452)
- Testing
- gut-brain axis (GLP-1)-activating food carbohydrate
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Indiana University
Alzheimer Disease Related Dementia
Probiotic Milk Drink for Gut and Brain Health in Older Adults and Caregivers
This double-blind, randomized, placebo-controlled clinical trial will evaluate the effects of a probiotic fermented milk (PFM) drink on gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and…
- Trial name
- PFM (NCT07800195)
- Testing
- Probiotic Fermented Milk (PFM) Drink
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of South Florida
Overweight and/or Obesity, Perimenopausal Women
Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity
People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal…
- Trial name
- INFLAME (NCT07501377)
- Testing
- Polybiotic dietary intervention
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences