Clinical trials: GI Tract Disorders
Renal Failure Chronic
Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease
Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.
- Trial name
- ProLowCKD (NCT04204005)
- Testing
- Probiotics
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Probiotical S.p.A.
Gut Health
Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms
- Trial name
- NCT06419231
- Testing
- Butyrate Formulation, Butyrate + Polyphenol Formulation
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Supplement Formulators, Inc.
Type 2 Diabetes, Chronic Obstructive Pulmonary Disease
Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease
This trial is a randomized, double-blind, parallel placebo clinical trial, the purpose of which is to investigate whether the adjuvant therapy of using probiotics during the treatment of diabetic patients can decrease blood sugar…
- Trial name
- NCT05492448
- Testing
- L. salivarius AP-32 and L. reuteri GL-104, L. reuteri GL-104
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Glac Biotech Co., Ltd
Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis
This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with…
- Conditions
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Colitis
- Trial name
- AIM-IBD (NCT07619638)
- Testing
- Microbiome-Targeting Nutraceutical
- Where
- Turkey (Türkiye)
- Volunteers
- 162 people
- Sponsor
- ENBIOSIS BIOTECHNOLOGIES
Gastrointestinal Diseases, Ileus
Gut Recovery In Patients Following Surgery
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral…
- Trial name
- GRIPS (NCT05712525)
- Testing
- G-Tech Wireless Patch System (WPS)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- G-Tech Corporation
Clostridium Difficile Infection
A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection
This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for…
- Trial name
- FMTREAT (NCT03053505)
- Testing
- faecal human microbiota transplant (FMT), Vancomycin or Fidaxomicin
- Where
- 3 sites in Hungary
- Volunteers
- 150 people
- Sponsor
- Sejtterapia Kozpont Kft.
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.
Gastrointestinal Cancer, Pancreatic Cancer
Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
The primary objective of this prospective observational study is to characterize the gut and oral microbiome as well as the whole blood transcriptome in gastrointestinal cancer patients and correlate these findings with cancer…
- Conditions
- Gastrointestinal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer
- Trial name
- NCT05462314
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Viome
Urea Cycle Disorders
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs).
- Trial name
- NCT03797131
- Testing
- KB195 (a novel mixture of oligosaccharides)
- Where
- Switzerland
- Volunteers
- 4 people
- Sponsor
- Kaleido Biosciences
Allergic Rhinitis
Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota
Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.
- Trial name
- NCT06680102
- Testing
- Probiotic, Maltodextrin
- Where
- China
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Wecare Probiotics Co., Ltd.
Type-II Diabetes
Postbiotic MBS and Metformin Combination in Patients With T2DM
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin.
- Trial name
- NCT04639492
- Testing
- MBS oral solution
- Where
- Taiwan
- Volunteers
- 14 people
- Sponsor
- Microbio Co Ltd
Low Mood
Effect of a Nutritional Supplement on Mental Wellness in Adults
Trillions of microbes reside in human gut and constitute "gut microbiota". Composition of these microbes and substances produced by them play an important role in human health and wellness.
- Trial name
- NCT06058364
- Testing
- Intervention 1 - Triglyceride
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Pharmavite LLC
Major Depressive Disorder (MDD, Anxiety Disorder, Generalized
Serotonin Variants & Gut Microbiota in Mental Health
This observational pilot study investigates whether a broad panel of genetic variants relevant to the serotonin pathway (including serotonergic system, methylation cycle, intestinal barrier integrity, and inflammatory response…
- Conditions
- Major Depressive Disorder (MDD, Anxiety Disorder, Generalized, Stress Disorders, Post-Traumatic, Panic Disorder
- Trial name
- NCT07634458
- Testing
- SNP Genotyping and Gut Metagenomics
- Volunteers
- 30 people
- Sponsor
- Neurobiologix
Overweight
Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
Before and after study in obese women 25-35 years old, BMI 30-35, taking Strath® Kräuterhefe Original (liquid), Herbal Yeast Food Supplement for three weeks.
- Trial name
- NCT03223987
- Testing
- Strath® Kräuterhefe Original (liquid)
- Where
- Switzerland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bio-Strath AG
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine. MGT-006 is an investigational oral capsule containing viable gut microbiota from screened human donors.
- Trial name
- ROOT (NCT07913347)
- Testing
- MGT-006, Vancomycin hydrochloride, Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole
- Where
- 12 sites in United States, Japan
- Volunteers
- 54 people
- Sponsor
- Metagen Therapeutics, Inc.
Ulcerative Colitis
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms
- Trial name
- NCT04508413
- Testing
- KB295
- Where
- 3 sites in United States, Ireland
- Volunteers
- 12 people
- Sponsor
- Kaleido Biosciences
Crohn's Disease
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
- Trial name
- RD-207 (NCT01576120)
- Testing
- bowel prep regimen first boost 6 oz. and second boost 3 oz., bowel prep regimen first boost 3 oz. and second boost 6 oz.
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Medtronic - MITG
Irritable Bowel Syndrome
The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions
The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C.
- Trial name
- NCT02888392
- Testing
- Kiwifruit, Psyllium
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Zespri International Limited
Advanced Cancer, Refractory Cancer
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are…
- Conditions
- Advanced Cancer, Refractory Cancer, Tumor Gastric
- Trial name
- NCT04861987
- Testing
- PCS6422 and capecitabine
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Processa Pharmaceuticals
Metabolic Syndrome, Gut Bacteria
Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
FLORA is a longitudinal intervention study with a randomized, parallel group design. Primary objective is to improve metabolic health through gut microbiota modulation by means of a retailer-driven personalized dietary…
- Conditions
- Metabolic Syndrome, Gut Bacteria, Personalized Nutrition
- Trial name
- FLORA (NCT04102891)
- Testing
- Microbiota modulation diet
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- SmartWithFood