Clinical trials: Gastrointestinal Microbiota
Microbiome Dysbiosis, Gut Health
Colon-delivered Riboflavin and Gut Microbiota Composition
Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs. conventional systemically available vitamin forms.
- Trial name
- CONCOL (NCT07093463)
- Testing
- Colon-delivered riboflavin, Conventional riboflavin, Microcrystalline Cellulose
- Where
- Germany
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Pre Diabetic
A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome
This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the Firmicutes phylum in the stool as well as the…
- Trial name
- NCT01724736
- Testing
- NM504:
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- NuMe Health
Fecal Microbiota Transplantation
Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality.
- Trial name
- HERACLES (NCT03359980)
- Testing
- fecal microbiota transfer
- Where
- 16 sites in France, Italy and 1 more
- Volunteers
- 24 people
- Sponsor
- MaaT Pharma
Gut Microbiome, Immune Responses
Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being
This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to…
- Conditions
- Gut Microbiome, Immune Responses, Well-being
- Trial name
- NCT07779265
- Testing
- Probiotic capsules
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Orthomol Pharmazeutische Vertiebs GmbH
Stress
CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?
This clinical trial will investigate whether a powdered prebiotic fibre blend can improve perceived stress levels in healthy adults with mild-severe stress levels.
- Trial name
- CALM (NCT07201909)
- Testing
- Prebiotic fibre blend, Maltodextrin powder
- Where
- United Kingdom
- Volunteers
- 156 people
- Sponsor
- Myota GmbH
Healthy, Human Gut Microflora
The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function
Diet and dietary ingredients can have a profound effect on gut microflora, both positive and negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut microflora are contradictory in some of the in…
- Trial name
- NCT05264636
- Testing
- Sucrose, Steviol Glycosides
- Where
- Canada
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Cargill
Vaccine Response Impaired, Vaccine Adverse Reaction
Vaccine Observation to Include All Communities for Equitable Science
VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool…
- Trial name
- VOICES (NCT04770649)
- Testing
- COVID-19 vaccine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Antibiotic Side Effect, Antibiotic-associated Diarrhea
Metagenomic and Metabolomic Reconstitution of Gut Microbiota After Broad Spectrum Antibiotic Therapy
In the United States, healthcare providers prescribe over 270 million antibiotic prescriptions each year. While antibiotics have transformed medicine and methods of treating life-threatening bacterial infection, broad spectrum…
- Conditions
- Antibiotic Side Effect, Antibiotic-associated Diarrhea, Antibiotic-induced Dysbiosis, Antibiotic-induced Epithelial Barrier Disintegrity
- Trial name
- NCT04171466
- Testing
- Ciprofloxacin + Metronidazole, SH-DS01
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Seed Health
Type 2 Diabetes
Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants
This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to…
- Trial name
- NCT06704022
- Testing
- Oral nutritional supplement
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Nimble Science Ltd.
Healthy Aging, Anti Aging
iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation on biological aging markers, metabolic health, and functional…
- Trial name
- VITAL (NCT07407894)
- Testing
- Bifidobacterium adolescentis iVS-1
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Synbiotic Health
Healthy Children
Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children
The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood.
- Trial name
- NCT04864665
- Testing
- a formula with prebiotics and milk fat
- Where
- 6 sites in China
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Microbiome, Metabolic Syndrome
Dietary Fibers Effect on the Gut Microbiota Composition
The randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of dietary fibers (8 g of either…
- Conditions
- Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor, Inflammation
- Trial name
- NCT04114513
- Testing
- Maltodextrin, Inulin, Pectin
- Where
- Russia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Atlas Biomed
Multiple Sclerosis, Relapsing-Remitting
Tecfidera and the Gut Microbiota
The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota.
- Trial name
- TECONGUT (NCT02471560)
- Testing
- dimethyl fumarate, injectable MS DMT
- Where
- 7 sites in Norway
- Volunteers
- 36 people
- Sponsor
- Biogen
Gastrointestinal Tolerance
A Double Blind Study on the Gastrointestinal Effects of Arabinoxylan (Leaf Fiber Extract).
The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults.
- Trial name
- NCT04100460
- Testing
- 7.25 grams of Arabinoxylan leaf fiber extract, 14.5 grams of Arabinoxylan leaf fiber extract, Control - No Arabinoxylan
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Comet Bio Inc.
Allergic Rhinitis
Probiotics Improve Adult Allergic Rhinitis and Regulate 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
- NCT06885346
- Testing
- Probiotic
- Where
- China
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Wecare Probiotics Co., Ltd.
Mild-to-Moderate COVID-19
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.
- Trial name
- NCT04486482
- Testing
- KB109 + Self Supportive Care (SSC), Self Supportive Care (SSC) Alone
- Where
- 12 sites in United States
- Volunteers
- 49 people
- Sponsor
- Kaleido Biosciences
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Dry Eye, Meibomian Gland Dysfunction (Disorder)
Effect of a Dietary Supplement on Gut Microbiota and Ocular Surface Outcomes in Dry Eye Disease
This prospective clinical study investigates whether a dietary supplement product can modulate the gut microbiota and improve ocular surface outcomes in patients with dry eye disease.
- Conditions
- Dry Eye, Meibomian Gland Dysfunction (Disorder), Dry Eye Disease (DED), Dry Eye Disease, Meibomian Gland Disease
- Trial name
- NCT07148271
- Testing
- Dietary Supplement Product
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Varol TUNALI
Human Microbiome
The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties
The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India.
- Trial name
- NCT04597502
- Testing
- Terminalia Chebula fruit extract, Topical Terminalia Chebula
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
Healthy Infants
Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27)…
- Trial name
- NCT07896083
- Testing
- Probiotic, Maltodextrin
- Where
- China
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- BYHEALTH Co., LTD