Clinical trials: Gut-brain Axis
Healthy
The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models.
- Trial name
- NCT03160066
- Testing
- Lactobacillus Rhamnosus (JB-1)
- Where
- Ireland
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- University College Cork
Irritable Bowel Syndrome
Exploring the Mechanism of a Probiotic Combination VSL#3 in Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Existing therapies for IBS are still far from satisfactory and new therapies are being constantly sought.
- Trial name
- NCT00786123
- Testing
- VSL#3
- Where
- Singapore
- Volunteers
- 40 people
- Sponsor
- National University Hospital, Singapore
Chronic Atrophic Gastritis, Depressive Symptoms
Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis
Depressive symptoms are highly prevalent in patients with chronic atrophic gastritis (CAG) but are frequently under-detected due to stigma and reliance on subjective questionnaires.
- Conditions
- Chronic Atrophic Gastritis, Depressive Symptoms, Depression, Gastrointestinal Diseases
- Trial name
- NCT07319338
- Testing
- Vascular-Psychological Triage Workflow
- Where
- 4 sites in China
- Volunteers
- 520 people
- Sponsor
- China Academy of Chinese Medical Sciences
Neural Response in Caudate, Weight Loss Trial
The Gut-brain Axis: a Novel Target for Treating Behavioral Alterations in Obesity
The aims of this project are to determine if dietary supplementation with NOPE-EGCG (PhosphoLeantm, 30mg NOPE+20mg EGCG per capsule) can: rescue striatal function, increase adherence to a diet, reduce weight-gain after a diet…
- Conditions
- Neural Response in Caudate, Weight Loss Trial, Impulsivity
- Trial name
- CIDO OEA (NCT01976156)
- Testing
- PhosphoLean
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Yale University
Crohn Disease
Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral…
- Trial name
- NCT06364722
- Testing
- Acupuncture treatment
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
Parkinson Disease, Irritable Bowel Syndrome
Early Signs of Parkinsons Disease in IBS
Bowel symptoms like constipation and abdominal pain are characteristic symptoms of irritable bowel syndrome (IBS). The pathogenesis and pathophysiology are not fully understood but subject to intense research, with emphasis on…
- Trial name
- NCT05573542
- Where
- Sweden
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Örebro University, Sweden
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
Irritable Bowel Syndrome
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood.
- Trial name
- NCT04691544
- Testing
- Fecal microbiota transplantation (FMT)
- Where
- Norway
- Volunteers
- 450 people
- Sponsor
- University Hospital of North Norway
Anxiety, Microbiome
Microbiome, Anxiety and Cognitive Orientation Study
Mounting evidence shows that the gut microbiome plays an important role in communication within the gut-brain axis. However, the relationship between gut microbiota and their influence on anxiety is still not fully understood.
- Conditions
- Anxiety, Microbiome, Mood Disorders, Neurodegeneration
- Trial name
- MACO (NCT05388630)
- Where
- United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Endominance
Premature Birth, Neurodevelopmental Disorders
Probiotics Supplementation for Neurodevelopment in Preterm Infants
The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure.
- Conditions
- Premature Birth, Neurodevelopmental Disorders, Dysbiosis
- Trial name
- NCT07617181
- Testing
- Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
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
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
Healthy Diet
Impact of Whole Grain Rye Bread on Health
This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut…
- Trial name
- FBS (NCT06333717)
- Testing
- Whole grain bread, Control bread
- Where
- Sweden
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Örebro University, Sweden
Stroke, Complication
Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia
Stroke-associated pneumonia (SAP) is the major complication of acute intracerebral haemorrhage (AICH), leads to poor clinical outcomes and increases the financial burden on the medical system.
- Trial name
- TFXSHF (NCT04275219)
- Testing
- Tongfu capsules
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Guangzhou University of Traditional Chinese Medicine
Stress Response, Mood State
Post-biotic Intervention for Acute Stress Management
The study aims to evaluate the sub-chronic effects of colonic delivery of a post-biotic on stress response, mood state, sleep, and cognition in healthy young subjects with elevated self-reported stress levels.
- Conditions
- Stress Response, Mood State, Sleep, Cognition
- Trial name
- PIAS (NCT06097182)
- Testing
- Post-biotic (Colonic-Delivery capsule), Post-biotic (Regular Administration capsule)
- Where
- Singapore
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Institute for Human Development and Potential (IHDP), Singapore
Menopause
Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis
Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in…
- Trial name
- SYMPTOGUT (NCT06333223)
- Testing
- Mixture of (Poly)phenols and a probiotic supplement
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Roehampton
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
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
The proposed pilot study aims to assess the underlying mechanisms of the MBI on IBS pain and the feasibility of using novel technology in the outcome measurements.
- Trial name
- NCT06706778
- Testing
- Music intervention
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Yale 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
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