Clinical trials: Fecal Microbiota
GVHD
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD
This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs.
- Trial name
- NCT05094765
- Testing
- FMT
- Volunteers
- 15 people
- Sponsor
- Shenzhen Xbiome Biotech Co., Ltd.
Microbial Colonization
Effect of Probiotics on Infant's Fecal Microbiota Composition
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants.
- Trial name
- BABYCARE (NCT05524649)
- Testing
- Food Supplement 1, Food Supplement 2
- Where
- 2 sites in Mexico, Spain
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- AB Biotics, SA
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
Fecal Microbiota Transplantation
Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder.
- Trial name
- NCT04861649
- Testing
- fecal microbiota transplantation
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Asclepius Meditec Inc.
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.
Leukemia, Myeloid, Acute
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients
The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal…
- Trial name
- ODYSSEE (NCT02928523)
- Testing
- Autologous Fecal Microbiota Transplantation
- Where
- 4 sites in France
- Volunteers
- 20 people
- Sponsor
- MaaT Pharma
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.
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
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
Irritable Bowel Syndrome (IBS)
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included.
- Trial name
- NCT02875847
- Testing
- HMO1, HMO2, Dextropur
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Glycom A/S
Sleep
Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota
The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in…
- Trial name
- NCT07243574
- Testing
- Increase sleep by 90 minutes, Decrease sleep by 90 minutes
- Where
- 3 sites in United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Danisco
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Child Nutrition Disorders
Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers
Food intake pattern and lifestyle are associated with the nutritional status and intestinal microbiota composition, and such factors are important for the proper growth and development during early childhood, as well as for the…
- Trial name
- Nutrilife (NCT02950740)
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
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.
SARS-CoV Infection
Efficacy of L. Plantarum and P. Acidilactici in Adults With SARS-CoV-2 and COVID-19
Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms.
- Trial name
- NCT04517422
- Testing
- Probiotics
- Where
- Mexico
- Volunteers
- 300 people
- Sponsor
- AB Biotics, SA
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
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.
Healthy Full Term Infants
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
The primary objectives of this trial are: to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp.
- Trial name
- NCT02031887
- Testing
- formula with synbiotics, formula without synbiotics
- Where
- 3 sites in South Africa
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Recurrent C. Difficile Infection
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4).
- Trial name
- PRISM4 (NCT05153499)
- Testing
- CP101
- Where
- 68 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- Finch Research and Development LLC.
Melanoma, Healthy Volunteers
Polish Microbiome Map
Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years.
- Conditions
- Melanoma, Healthy Volunteers, Microbiome, Metagenome
- Trial name
- NCT04169867
- Testing
- Collection of stool samples
- Where
- Poland
- Volunteers
- 1,160 people, healthy volunteers welcome
- Sponsor
- Ardigen