Gut Microbiota Clinical Trial
— XOSOfficial title:
A Double-blind, Placebo-controlled, Randomized Crossover Study to Determine the Effects of Xylooligosaccharides (XOS), B. Lactis (BI07) and XOS + BI07 Upon the Gut Microbiota and Immune Response of Healthy Volunteers
Verified date | March 2012 |
Source | University of Reading |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Healthy volunteers will be recruited to a study where they will be given four different treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be collected and analysed for changes in faecal microbial populations and selected immune responses.
Status | Completed |
Enrollment | 44 |
Est. completion date | January 2010 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - signed consent form - age 25-65 years - body mass index 20-30 inclusive - good general health as determined by medical questionnaires - additional inclusion criteria: as far as possible, target volunteer group will have mild constipation (bowel movement of less than 1/day, hard stool consistency) Exclusion Criteria: - • Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study - History of drug abuse, including alcohol - Severe allergy or a history of severe abnormal drug reaction - Participation in experimental drug trial within four weeks prior to study - Participation in prebiotics or laxative trial within the previous three months - Use of antibiotics within the previous six months - Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint - Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study - Use of prescribed medication - Regular use of aspirin or other anti-inflammatory drugs |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Reading | Reading | Berkshire |
Lead Sponsor | Collaborator |
---|---|
University of Reading | Danisco |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes to the gut microbiota | Changes in faecal bacterial populations will be assessed through the use of FISH with molecular probes targeting 16S rRNA genes. Genotypic probes targeting the predominant components of the gut microflora (Bacteroides, Bifidobacterium, Clostridium, Lactobacillus, Eubacterium, Atopobacterium, Streptococcus, sulphate reducing bacteria and enterobacteria) and total bacteria will be tagged with fluorescent markers such that quantifiable changes may be determined. Concentrations of short chain fatty acids (SCFA) will be quantified using gas chromatography (GC). | 7 months | No |
Secondary | Bowel function, immune function and plasma lipids | This will be achieved using volunteer diaries of bowel function and mood, and by investigating total plasma lipids, mucosal immunity (salivary and faecal IgA), total leukocyte numbers, expression of cell surface markers on immune cells to identify cell subsets and activation markers, production of inflammatory markers by whole blood cultures, plasma chemokines, phagocytosis and oxidative burst by monocytes and granulocytes, plasma/serum immunoglobulins, acute phase proteins, complement proteins and soluble adhesion molecules. | 7 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04991792 -
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section
|
N/A | |
Completed |
NCT02151825 -
Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects
|
N/A | |
Active, not recruiting |
NCT04435548 -
Westlake Gut Microbiome Study
|
||
Enrolling by invitation |
NCT05057039 -
The Study of Gut Microbiota in Hypertensive Patients
|
||
Not yet recruiting |
NCT05039060 -
Modified MAC Diet and Gut Microbiota in CRC Patients
|
N/A | |
Completed |
NCT03746158 -
Interindividual Variation in Excretion of Curcumin
|
N/A | |
Active, not recruiting |
NCT03266055 -
Effects of Blueberry on Gut Microbiota and Metabolic Syndrome
|
N/A | |
Completed |
NCT04960878 -
The Effect of Synbiotics on the Upper Respiratory Tract Infection
|
N/A | |
Active, not recruiting |
NCT05607745 -
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
|
N/A | |
Recruiting |
NCT04120051 -
The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults
|
N/A | |
Not yet recruiting |
NCT05481866 -
Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum
|
N/A | |
Completed |
NCT03293693 -
Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects
|
N/A | |
Completed |
NCT02207140 -
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
|
Phase 0 | |
Recruiting |
NCT04203459 -
The Mechanism of Enhancing the Anti-tumor Effects of CAR-T on PC by Gut Microbiota Regulation
|
||
Active, not recruiting |
NCT03259685 -
Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome
|
N/A | |
Recruiting |
NCT06157346 -
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
|
||
Completed |
NCT03203044 -
Impact of Soylent Consumption on Human Microbiome Composition
|
N/A | |
Recruiting |
NCT05975541 -
Susceptibility to Infectious Diseases in Obesity
|
||
Active, not recruiting |
NCT05457439 -
Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment
|
N/A | |
Recruiting |
NCT05008120 -
Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder
|