Clinical trials: GI Tract Disorders
Asphyxia Neonatorum, Morbidity;Newborn
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
- Trial name
- VISNAT (NCT04145713)
- Testing
- Probiotic mixture
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Policlinico Hospital
Gut Microbiota, Epilepsy
MiCrobiota-gut-brain Axis in Resistant Epilepsy
Epilepsy is one of the most common neurological chronic conditions with a serious burden on patients, their caregivers, and society. Drug-resistant epilepsy (DRE) heightens this burden. New approaches are thus a priority.
- Conditions
- Gut Microbiota, Epilepsy, Drug-Resistant Epilepsy
- Trial name
- CARE (NCT07010445)
- Testing
- Naïve: epilepsy first diagnosis,, DRE-surgery: resective surgery;, anti-epileptic drugs;
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Niguarda Hospital
Pediatric Crohns Disease
Clinical Hypnosis in Pediatric Crohn's Disease
Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, immune-mediated disease increasingly prevalent in youth.
- Trial name
- HypnoCrohns (NCT03809195)
- Testing
- Clinical Hypnosis
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Vanderbilt University Medical Center
Type 1 Diabetes, Obesity
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications.
- Trial name
- NCT05414409
- Testing
- Metformin
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Heba M. Ismail
Pregnancy Related, Pregnancy Loss
Microbiome and Malnutrition in Pregnancy
This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby.
- Conditions
- Pregnancy Related, Pregnancy Loss, Pregnancy Complications, Pregnancy; Parasitic Disease
- Trial name
- MMIP (NCT04992104)
- Where
- 2 sites in Canada
- Volunteers
- 800 people
- Sponsor
- The Hospital for Sick Children
Gut Microbiome
Gut Microbiome and Metabolic Pathways Changes in Vitiligo
Vitiligo is a chronic depigmenting autoimmune-associated skin disease and a growing psychological health concern because of its low quality of life.
- Trial name
- NCT03797417
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Xijing Hospital
Inflammatory Bowel Disease (IBD)
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure.
- Trial name
- GMT (NCT01560819)
- Testing
- Gut Microbial Transplantation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Corewell Health West
Prader-Willi Syndrome
Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment
The gut microbiome has recently emerged as a major contributor to obesity, systemic inflammation, and metabolic disease. Furthermore, intestinal bacteria are crucial players in the gut-brain axis, regulating a broad range of…
- Trial name
- BALPWS (NCT03548480)
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 39 people
- Sponsor
- Fundació Sant Joan de Déu
Alcoholic Liver Disease
Gut Mycobiome Profile in Alcoholic Liver Disease.
The fecal mycobiome, which refers to the community of fungi that resides in the human gut, is an important component of the gut microbiome.
- Trial name
- NCT05793190
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Chuncheon Sacred Heart Hospital
Inflammatory Bowel Disease, Crohn's Disease
The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease
Background: Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an important role in a person s health. The gut microbiome helps to regulate the immune system and control inflammation.
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- Trial name
- NCT05652491
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome
Hypnotherapy vs. Probiotics in Children With IBS and Functional Abdominal Pain
Current study aims to investigate the influence of gut-directed hypnotherapy and probiotic nutritional supplement (SymbioLact B) on gastrointestinal symptoms in children with functional abdominal pain or irritable bowel syndrome…
- Trial name
- NCT02613078
- Testing
- Gut-Directed Hypnotherapy, Nutritional Supplement, Self-Monitoring
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital Tuebingen
Cystic Fibrosis
Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor
Cystic fibrosis is a systemic disease, which affects in particular the respiratory and digestive systems of patients, sites of chronic inflammation.
- Trial name
- KAF-BIOTA (NCT05937815)
- Testing
- Sample collection
- Where
- 15 sites in France
- Volunteers
- 253 people
- Sponsor
- University Hospital, Bordeaux
Autism Spectrum Disorder
A Deep Learning Algorithm Platform to Predict Autism Diagnosis and Subtypes
This is the first human study on ASD microbiome with robust methodologies: prospective and sibling designs, metagenomics profiles, establishing an ASD multi-dimensional databank (clinic, behavior, neurocognition, brain imaging…
- Trial name
- NCT04873674
- Testing
- ASD diagnosis, Psychiatric diagnosis
- Where
- Taiwan
- Volunteers
- 420 people
- Sponsor
- National Taiwan University Hospital
Crohn Disease
Mother-to-Infant Transfer of Bacteriome, Fungome, Virome, and Metabolome in Health and Crohn's Disease
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.
- Trial name
- NCT05112497
- Testing
- No intervention procedure
- Where
- Hong Kong
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Water-Related Diseases
SAFEWATER Health & Behaviour Impact Field Trials; Mexico
At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal…
- Trial name
- NCT04736615
- Testing
- SAFEWATER systems for drinking water disinfection, Behavior change interventions
- Where
- 3 sites in Colombia, Mexico
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Sleep Deprivation, Gut Microbiota
Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters
Oral, fecal and conjunctival samples will be collected from participants and will be stored (at - 20 and - 80 ◦C) until further processing.
- Conditions
- Sleep Deprivation, Gut Microbiota, Optometry Examinations, Oral Microbiota
- Trial name
- NCT06638606
- Testing
- Sleep improvement techniques
- Where
- Iran
- Volunteers
- 1,740 people, healthy volunteers welcome
- Sponsor
- Reza Rastmanesh
Obesity, Childhood, Insulin Resistance
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose…
- Trial name
- NCT04578652
- Testing
- Metformin 850 mg oral tablet bid, Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Alberta
Congenital Heart Disease
Calprotectin and Gut Disease Study
Necrotising enterocolitis (NEC) is a serious gut disease that can develop in infants born with cardiac defects. It causes inflammation and injury to the gut mucosa and may be life-threatening.1 The aetiology of NEC in cardiac…
- Trial name
- SAFE NEC (NCT07112794)
- Volunteers
- 300 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Obesity, PreDiabetes
Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes
This study intends to assess the role of inflammation in insulin resistant conditions (i.e., obesity and pre-diabetes) and the subsequent development of disease, such as type 2 diabetes (T2D) and cardiovascular disease (CVD), in…
- Conditions
- Obesity, PreDiabetes, Adolescent Obesity, Inflammation
- Trial name
- MI4D (NCT04031222)
- Where
- Canada
- Volunteers
- 52 people
- Sponsor
- The Hospital for Sick Children
Autism Spectrum Disorder, Autism
Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectral Disorder
- Trial name
- GARM-Autism (NCT07546942)
- Testing
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Black Tie Medical, Inc.