Clinical trials: Gut-brain Axis
Traumatic Brain Injury
Long-term Recovery and Microbiota-Gut-Brain Axis Disruption After Traumatic Brain Injury
The OVERCOME-TBI project aims to collect multimodal data approximately 1-4 and 11-14 years after an earlier well-documented traumatic brain injury (TBI) and examine factors that influence disease progression in order to gain new…
- Trial name
- OVERCOME-TBI (NCT06927063)
- Testing
- blood-based protein biomarker assessments, blood-based metabolomic/lipidomic biomarker assessments, Diffusion-weighted magnetic resonance imaging (brain)
- Volunteers
- 160 people
- Sponsor
- Turku University Hospital
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
Healthy Young Adults
Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™
The purpose of this study is to evaluate changes in self-reported wellbeing outcomes in adolescents. Bifidobacterium longum, 1714™ has previously been associated with beneficial effects on stress-related outcomes, sleep quality…
- Trial name
- NCT07752342
- Testing
- Bifidobacterium longum, 1714™
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Novonesis
Obesity
Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse
The primary aim of this work is, to 'relate psychological and behavioural parameters of hunger/satiety and food preference to gut hormones, neural activation and energy metabolism by dietary manipulation, across the human…
- Trial name
- F4H (NCT01597024)
- Testing
- Breakfast Study, fMRI Study
- Where
- 3 sites in Greece, Netherlands and 1 more
- Volunteers
- 718 people, healthy volunteers welcome
- Sponsor
- University of Aberdeen
Epilepsy, Microbiota
EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE
The goal of this observational study is to learn how the bacteria in the gut and mouth (called the microbiota) are linked to different types of epilepsy and how they may affect how well seizure medicines work.
- Conditions
- Epilepsy, Microbiota, Proteomics, Metabolomics
- Trial name
- EpiGUT (NCT07253701)
- Where
- 6 sites in Sweden
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Karolinska Institutet
Functional Abdominal Pain Syndrome
The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders
Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless…
- Trial name
- NCT06310733
- Testing
- LGG
- Where
- Thailand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Prince of Songkla University
Crohn's Disease
Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake
Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood.
- Trial name
- NCT02772458
- Testing
- Dodecanoate acid and saline
- Where
- 2 sites in United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Nottingham
Major Depressive Disorder, Bipolar Disorder, Mixed
Chinese Longitudinal and Systematic Study of Bioplar Disorder
Affective disorders (mainly including major depressive disorder and bipolar disorder) are common, chronic and highly disabling mental disorders, which lack of objective biological markers.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Mixed, Affective; Disorder, Organic
- Trial name
- CLASS-BD (NCT05480150)
- Testing
- Escitalopram Oxalate Tablets, Quetiapine Fumarate Tablets, Lurasidone
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Autism Spectrum Disorder
Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that affects communication, behavior, sensory processing, and daily functioning.
- Trial name
- GAIN-ASD (NCT07646808)
- Where
- India
- Volunteers
- 600 people
- Sponsor
- Saveetha University
Anorexia Nervosa
The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa
Anorexia Nervosa (AN) is a severe, debilitating and potentially life threatening illness that is difficult to treat. A cardinal symptom of AN is the mistaken belief on the part of the individuals that they are overweight and must…
- Trial name
- NCT07143981
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome
Autonomic Reactivity and Personalized Neurostimulation
Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc).
- Conditions
- Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome, Functional Dyspepsia, Dysautonomia
- Trial name
- NCT06863207
- Testing
- Percutaneous electrical nerve field stimulation, Hypnotherapy
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Meconium Obstruction of Prematurity
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
The goal of this clinical trial is to study the effect of twice-daily saline enema (SE) in the treatment obstruction of prematurity (MOP) in infants with the birth weight ≤1.25kg.
- Trial name
- NCT06048614
- Testing
- Saline Enema (SE), Glycerin Suppository
- Where
- 2 sites in Singapore
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- KK Women's and Children's Hospital
Autism Spectrum Disorder
Randomized Double-blind Clinical Trial With L.Reuteri Supplementation in Children With Autism Spectrum Disorder
The aim of this study is to assess the effects of a 6-months probiotic supplementation on behavioral profiles, microbiota and metabolic profiles, inflammatory biomarkers, gastrointestinal disturbances, in children with Autism…
- Trial name
- NCT04293783
- Testing
- L.Reuteri
- Where
- 2 sites in Italy
- Volunteers
- 43 people
- Sponsor
- University of Rome Tor Vergata
Obesity, Childhood
GI Tract Biomarkers in Infants With Different Diets
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity.
- Trial name
- NCT03751137
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Attention Deficit Hyperactivity Disorder, Anxiety
Effects of a Probiotic Supplement on Symptoms of Attention Deficit Hyperactivity Disorder and Anxiety in Children
The study will examine the effect of a probiotic supplement (Lactobacillus helveticus R0052 and Bifidobacterium Longum R0175) dissolved in a dairy product such as milk or ice-cream on symptoms of ADHD and anxiety in children.
- Trial name
- NCT02545634
- Testing
- L. helveticus R0052 and B. longum R0175
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Acadia University
Autism Spectrum Disorder
WMT for Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two-thirds with ADHD show ASD…
- Trial name
- NCT06030752
- Testing
- Washed Microbiota Transplantation
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- The Second Hospital of Nanjing Medical University
Autism Spectrum Disorder
Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters
The purpose of this study is to assess the effects of a 6-months supplementation with probiotic Vivomixx® on inflammatory and gastrointestinal (GI) biomarkers, gastrointestinal disturbances, behavioral and developmental profiles…
- Trial name
- NCT02708901
- Testing
- Vivomixx®
- Where
- Italy
- Volunteers
- 85 people
- Sponsor
- IRCCS Fondazione Stella Maris
Preterm, Neurodevelopmental Disorders
Dietary Pattern Intervention for Neurodevelopment in Preterm Infants
The purpose of this randomized controlled trial is to evaluate the effect of a structured, high-prebiotic dietary pattern on the neurodevelopmental outcomes of preterm infants.
- Conditions
- Preterm, Neurodevelopmental Disorders, Dysbiosis
- Trial name
- NCT07702734
- Testing
- Structured High-Prebiotic Dietary Pattern
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD
The primary goals of this phase 2 clinical trial are to determine the feasibility, safety, and tolerability of oral Fecal Microbiota Transplantation (FMT) in adolescents (aged 13-17) with Attention-Deficit/Hyperactivity Disorder…
- Conditions
- ADHD, ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
- Trial name
- FMT-ADHD-2026 (NCT07756255)
- Testing
- Fecal Microbiota Transplant (FMT), Nitazoxanide 500mg BID, Vancomycin 250mg BID
- Where
- Canada
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Calgary
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