Clinical trials: Microbiome
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Infant Development, Stress
Multisensory Early Oral Administration of Human Milk in Preterm Infants
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation.
- Trial name
- M-MILK (NCT06230848)
- Testing
- Multisensory Early Oral Administration of Human Milk (M-MILK)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Loyola University
Hematopoietic Stem Cell Transplantation (HSCT), Acute GVH Disease
Gut Decontamination In Pediatric Allogeneic Hematopoietic
This research study is for participants who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) and are at risk for developing acute graft-versus-host disease (GVHD).
- Trial name
- NCT02641236
- Testing
- Vancomycin-polymyxin B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Dana-Farber Cancer Institute
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Malaria
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes…
- Trial name
- NCT04336189
- Testing
- Sulfadoxine-pyrimethamine (SP), Dihydroartemisinin-piperaquine (DP)
- Where
- Uganda
- Volunteers
- 2,757 people, healthy volunteers welcome
- Sponsor
- Grant Dorsey, M.D, Ph.D.
Type 1 Diabetes
The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched…
- Trial name
- NCT02867436
- Testing
- Gluten-free diet
- Where
- 2 sites in Czechia
- Volunteers
- 45 people
- Sponsor
- University Hospital, Motol
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
Infant Development, Gut Microbiome
INF108F in Infants With Food Protein Induced Proctocolitis
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
- Conditions
- Infant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis
- Trial name
- RESTORE (NCT05793112)
- Testing
- INF108F probiotic
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Diabetes
Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Background: Metformin is a pill youth with type 2 diabetes take. It can cause side effects like diarrhea and upset stomach. Researchers want to see if a fiber supplement can help decrease these side effects.
- Trial name
- NCT04209075
- Testing
- Biomebliss, Metformin
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Early Childhood Caries
A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children
Silver diamine fluoride (SDF) is an antibiotic liquid that has the potential to arrest Early Childhood Caries in young children and delay treatment until children can be seen in outpatient settings.
- Trial name
- NCT04054635
- Testing
- Silver diamine fluoride
- Where
- Canada
- Volunteers
- 84 people
- Sponsor
- University of Manitoba
Crohn Disease, Pediatric Crohns Disease
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to…
- Trial name
- PAZAZ (NCT04186247)
- Testing
- Azithromycin, Metronidazole, Standard of Care
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 13 people
- Sponsor
- University of North Carolina, Chapel Hill
Iron-deficiency
Prebiotic GOS and Lactoferrin With Iron Supplements
The ultimate goal of this research is to develop a means to safely administer iron supplements to infants in settings with a high infection burden.
- Trial name
- NCT03866837
- Testing
- Galacto-oligosaccharides, Bovine lactoferrin, Multiple micronutrient powders with 5 mg iron
- Where
- 2 sites in Kenya, Switzerland
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Columbia University
Child Development
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome.
- Trial name
- ARMCA (NCT03187834)
- Testing
- Azithromycin, Amoxicillin, Cotrimoxazole
- Where
- 2 sites in United States, Burkina Faso
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Chalazion
Probiotics for Chalaziosis Treatment in Children
There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by…
- Trial name
- NCT04322500
- Testing
- probiotics, conservative treatment
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- University of Molise
Type 1 Diabetes
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain…
- Trial name
- NCT04114357
- Testing
- Acetylated and Butyrylated High Amylose Maize Starch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Indiana University
Lower Urinary Tract Symptoms
Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB
As a collaborative effort between MedStar National Rehabilitation Hospital (NRH), Children's National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research…
- Trial name
- NCT02748356
- Testing
- Lactobacillus
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Medstar Health Research Institute
Autism Spectrum Disorders, Anxiety
Probiotics for Quality of Life in Autism Spectrum Disorders
A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.
- Trial name
- NCT02903030
- Testing
- Visbiome Extra Strength
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Ohio State University
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Autistic Disorder
28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder
SB-121 is being developed for use in the treatment of autistic disorder (AD). This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study.
- Trial name
- NCT04944901
- Testing
- SB-121
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Scioto Biosciences, Inc.
Anxiety, Abdominal Pain
The Probiotic Study: Using Bacteria to Calm Your Mind
The investigators seek to conduct the first open-label trial of probiotics in young children to reduce their anxiety and abdominal pain.
- Trial name
- NCT02711800
- Testing
- Lactobacillus rhamnosus
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Nancy Zucker