Clinical trials: Microbiome Composition
Parkinson Disease
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
48 PD patients (age 35-75y; H\&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion.
- Trial name
- NCT04854291
- Testing
- Administration of donor FMT
- Where
- 4 sites in Finland
- Volunteers
- 51 people
- Sponsor
- Helsinki University Central Hospital
Spontaneous Abortion
Composition of the Intestinal Microbiome in Patients With Recurrent Spontaneous Abortions.
Up to 50% of all women suffer of a spontaneous abortion. Having two/three or more spontaneous abortions is one of the main reasons of unwanted childlessness.
- Trial name
- NCT07246486
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Dr. Natascha Köstlin-Gille
Poor Sleep Quality, Gut Microbiome
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure…
- Conditions
- Poor Sleep Quality, Gut Microbiome, Gut Health, Inflammation
- Trial name
- NCT07848594
- Testing
- Overnight Active Temperature Regulation: Eight Sleep Pod System
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eight Sleep Inc.
Obesity
Dairy Intervention in People With Obesity
Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects.
- Trial name
- DIPO (NCT04154475)
- Testing
- yogurt diet, dairy diet, standard diet
- Where
- Austria
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Vitamin B 12 Deficiency
The Impact of Vitamin B12 Deficiency on Infant Gut Microbiota
Vitamin B12 plays important roles in DNA synthesis and neurological functions. Vitamin B12 deficiency is one of the most common micronutrient deficiencies and it has become increasingly more frequent in infants.
- Trial name
- NCT03365583
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Marmara University
Sleep, Gut Microbiome
Impact of Nutritional Supplementation on Sleep Quality and Gut Microbiome Composition in Older Adults
The aim of this study is to assess the impact of 5-hydroxytryptophan (5-HTP) supplementation on sleep quality and gut microbiome composition in older adults with normal cognition vs.
- Trial name
- NCT04078724
- Testing
- 5-HTP, Without 5-HTP
- Where
- 2 sites in Singapore
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National University of Singapore
Gut Microbiota
Impact of Soylent Consumption on Human Microbiome Composition
Soylent 2.0 is a popular meal replacement drink that is used to supplement or replace one's regular diet. Soylent is designed to fully fulfill one's nutritional needs, but its impact on the human microbiome remains unknown.
- Trial name
- NCT03203044
- Testing
- Soylent and water diet
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Transplantation Infection, Kidney Transplant; Complications
Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients
This is a pilot study designed to investigate the alterations in the gut microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic hematopoietic stem cells and mesenchymal stem cells…
- Conditions
- Transplantation Infection, Kidney Transplant; Complications, Stem Cell Transplant Complications, Liver Transplant; Complications
- Trial name
- NCT04281797
- Testing
- Intestinal microbiome new generation sequencing
- Where
- Belarus
- Volunteers
- 90 people
- Sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Obesity, Well-being
Gut Microbiome and Blood Markers After Habitual Herbal Tea Consumption
TeTrimTeas intends is to establish a long-term cooperative with local growers and producers who will become partners in the business, with profit share to local growers and producers.
- Trial name
- SRTT (NCT05862532)
- Testing
- TeTrimTeas welsh Herbal tea with rhubarb root, TeTrimTeas welsh Herbal tea with senna, TeTrimTeas welsh Herbal tea with green tea
- Where
- United Kingdom
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Aberystwyth University
Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
The objective of this study is to test whether dietary behavior modification impacts diet quality and stool microbiome composition and metabolism using microbial whole genome sequencing, targeted metabolomics, and immune…
- Trial name
- NCT06091813
- Testing
- Nutrition Counseling
- Where
- United States
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Pregnancy, Gestational Weight Gain
Maternal Gestational Weight Gain and Microbiota of Maternal and Infant
A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and…
- Conditions
- Pregnancy, Gestational Weight Gain, Microbiota
- Trial name
- NCT03916354
- Where
- China
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Biomarkers of B-vitamin Status and Gut Microbiome Composition
Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults (GutFood)
Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes.
- Trial name
- NCT07592975
- Testing
- Inulin and B-vitamins, Inulin
- Where
- United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Crohn Disease
Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Crohn's Disease
Crohn's disease (CD) is an inflammatory bowel disease in which there is an alteration of the homeostasis and functionality of the intestinal mucosa accompanied by a dysbiosis of the commensal microbiota.
- Trial name
- NCT06933264
- Testing
- Exclusion diet
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Hospital Universitario Virgen de la Arrixaca
Pilot Study
How Differences in the Composition of Microorganisms in the Soil Affect the Microorganisms in the Human Gut, Through the Vegetables That Grow in it: a Process Pilot Study With Healthy Participants
There are two objectives for this clinical trial. The first is to test whether, with the current logistics and study setup it is possible to perform the study well and see where there might be bottlenecks we couldn't predict.
- Trial name
- HUMANITAS (NCT07742319)
- Testing
- Low diversity vegetable smoothie, High diversity vegetable smoothie
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Gastrointestinal Diseases, Colic
Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics
The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic…
- Trial name
- NCT02865564
- Testing
- Lactobacillus reuteri DSM 17938, ampicillin and gentamicin
- Where
- Slovenia
- Volunteers
- 98 people
- Sponsor
- University Medical Centre Ljubljana
Chemotherapy-Related Nausea and/or Vomiting, Early Stage Breast Carcinoma
Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer
This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for…
- Conditions
- Chemotherapy-Related Nausea and/or Vomiting, Early Stage Breast Carcinoma, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT05417867
- Testing
- Biospecimen Collection, Questionnaire Administration
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mayo Clinic
Sex Hormones, Microbial Colonization
The Relationship of the Intestinal Microbiome and the Menstrual Cycle
In the present study the dynamic changes of the intestinal microbiome are observed over a 4-week period in the different stages of the menstrual cycle in women at childbearing age.
- Trial name
- NCT03581201
- Testing
- Laboratory measurements, Stool samples, Bioimpedance analysis
- Where
- Austria
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Colorectal Polyp, Inflammation
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy.
- Conditions
- Colorectal Polyp, Inflammation, Dietary Intervention, Microbiota
- Trial name
- NCT06603519
- Testing
- Modified Plant-Based Mediterranean Diet
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Non-Hodgkin Lymphoma, DLBCL
Diet, Physical Activity and Body Composition Changes During R-CHOP
In this pilot study, observational data will be collected to describe the usual trajectory of changes in dietary intake, ability to be physically active, body composition, environmental exposures, and the gut microbiome over the…
- Conditions
- Non-Hodgkin Lymphoma, DLBCL, Diffuse Large B Cell Lymphoma
- Trial name
- R-CHOP-OS (NCT04293900)
- Testing
- 24-hour dietary recall, Hand grip strength, International Physical Activity Questionnaire
- Where
- United States
- Sponsor
- George Washington University
Healthy
Batch Fermentation and Microbiome Analysis
The correlation between diet and microbiota as well as the effect of microbiota on human health is well established. Studies have shown that people following specific diets have different microbiome profile compared to those…
- Trial name
- NCT06097130
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)