Clinical trials: Fecal Microbiota
Fecal Microbiota
Exploratory/Proof of Principle Microbiota Study
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that…
- Trial name
- NCT02500563
- Testing
- Amino acid based infant formula, Extensively hydrolyzed casein infant formula, Mother's own breast milk
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Infection
Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out.
- Trial name
- P010 (NCT00724204)
- Testing
- follow on formula without probiotics, follow on formula with Lactobacillus salivarius CECT5713
- Where
- Spain
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Puleva Biotech
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
COVID-19
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.
In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to…
- Trial name
- EDIFICE (NCT05107245)
- Testing
- 1test1
- Where
- 4 sites in France
- Volunteers
- 143 people
- Sponsor
- Luxia Scientific
Antibiotic Resistant Bacteria
Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas
A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites.
- Trial name
- ANTIRESDEV (NCT02030912)
- Testing
- 3 doses of amoxicillin daily for 7 days, 2 doses of minocycline daily for five days
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Helperby Therapeutics 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
Enterocolitis Clostridium Difficile Recurrent
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C.
- Trial name
- PUNCHCD2 (NCT02299570)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 21 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Rebiotix Inc.
Gut Microbiota, Gastrointestinal Symptoms
The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers
The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. A total of 100 male and female volunteers will be included.
- Trial name
- HMO-VOL (NCT01927900)
- Testing
- HMO, Glucose
- Where
- Denmark
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glycom A/S
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.
Type 2 Diabetes, Metabolic Syndrome
Clinical Study on the Effect of a Synbiotic on Body Fat Mass
In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors…
- Conditions
- Type 2 Diabetes, Metabolic Syndrome, Obesity, Abdominal, Obesity, Visceral
- Trial name
- NCT04754464
- Testing
- synbiotic, microcrystalline cellulose
- Where
- 2 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Slimbiotics GmbH
Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible…
- Conditions
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI
- Trial name
- PRISM-EXT (NCT03497806)
- Testing
- CP101
- Where
- 57 sites in United States, Canada
- Volunteers
- 132 people
- Sponsor
- Finch Research and Development LLC.
Quality of Life, Health, Subjective
Resistant Starch Blend Gastrointestinal Impact
This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in…
- Trial name
- NCT03983772
- Testing
- RS blend
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Metagenics, Inc.
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.
Focus of the Study is on Gut Health
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods.
- Trial name
- NCT01518088
- Testing
- Dietary Fiber
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ingredion Incorporated
Glucose Intolerance, Microbial Colonization
Effects of Tagatose on Glycemic Response and Gastrointestinal Microbiota in Healthy Adults
The primary objective of this clinical-trial is to determine, in subjects with impaired fasting glucose (IFG) and/or insulin resistance (IR), if tagatose meets the definition of a prebiotic, namely that consuming tagatose for 4…
- Trial name
- NCT06920641
- Testing
- Tagatose
- Where
- Canada
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Healthy Volunteers
The Effects of Daily Supplementation of a Soluble Fiber on the Fecal Microbiota in Volunteers.
The effects of daily supplementation with NUTRIOSE® on the fecal microbiota. The study aims to evaluate the ability of NUTRIOSE® to support a beneficial modulation of the intestinal microbiota in healthy volunteers, compared with…
- Trial name
- NUTRIPOWER (NCT07846254)
- Testing
- NUTRIOSE®, Active comparator
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Roquette Freres
A03 - Digestive System, 03 - Bacteria
Stool Collection for Model
Purpose of this study is to collect stool samples from healthy volunteers
- Trial name
- StoColM (NCT06988514)
- Testing
- Standardized stool collection from healthy volunteers
- Where
- France
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
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
Intensive Care Units, Fecal Microbiota Transplantation
Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism.
- Trial name
- HAPY3 (NCT03350178)
- Testing
- fecal microbiota transfer
- Where
- 2 sites in France
- Volunteers
- 8 people
- Sponsor
- MaaT Pharma
Follow-on Formula, Infant
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will…
- Conditions
- Follow-on Formula, Infant, Faeces, Gut Microbiota
- Trial name
- FUNTASTIC (NCT07207109)
- Testing
- Test: Follow-on formula with synbiotics, Control: Regular follow-on formula
- Where
- 2 sites in Indonesia
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Nutricia Research