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A Study of a Prebiotic, a Probiotic and a Synbiotic Upon the Gut Microbiota and Immune Response of Healthy Volunteers (XOS)

This study has been completed.
Sponsor:
Collaborator:
Danisco
Information provided by (Responsible Party):
Caroline Childs, University of Reading
ClinicalTrials.gov Identifier:
NCT01545219
First received: February 29, 2012
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Gut Microbiota
Bowel Function
Immune Function
Plasma Lipids
 Dietary Supplement: Prebiotic
Dietary Supplement: Bi-07
Dietary Supplement: Synbiotic
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Changes to the gut microbiota [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Bowel function, immune function and plasma lipids [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prebiotic Dietary Supplement: Prebiotic
8g/day xylo-oligosaccharide
Experimental: Probiotic Dietary Supplement: Bi-07
10^9 CFU B. lactis / day
Experimental: Synbiotic Dietary Supplement: Synbiotic
8g/day xylo-oligosaccharide + 10^9 CFU Bi-07
Placebo Comparator: Placebo Dietary Supplement: Placebo
8g/day maltodextrin

Detailed Description:

The primary objective of this study is to determine the effect of XOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic combination of both (8g/day XOS and 109 CFU/day B. lactis BI07) on the human gut microbiota.

A double-blind, placebo-controlled, randomized crossover study will be conducted in 44 healthy volunteers. The placebo will be maltodextrin (a food grade ingredient, administered at 8g/day).

Changes in the gut microbiota will be determined by measuring bacterial population levels in human faeces using fluorescence in situ hybridisation (FISH) with 16S rRNA targeted oligonucleotide probes. Concentrations of short chain fatty acids (SCFA) will be quantified using gas chromatography (GC).

In addition to analyses performed on the samples at the University of Reading, analyses on microbial metabolites and selected members of the microbiota will also be performed at Danisco Finland, Kantvik. University of Reading will therefore provide Danisco Kantvik with faecal samples of appropriate size.

The secondary objective of this study is to examine the effects of XOS (8g/day), B. lactis BI07 (109 CFU/day) and the synbiotic (8g/day of XOS and 109 CFU/day of B. lactis BI07) on bowel function, immune function and plasma lipids in 44 healthy volunteers. 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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545219

Locations
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Danisco
Investigators
Principal Investigator: Glenn R Gibson, BSc, PhD University of Reading
  More Information

No publications provided

Responsible Party: Caroline Childs, Post doctoral research fellow, University of Reading
ClinicalTrials.gov Identifier: NCT01545219     History of Changes
Other Study ID Numbers: 08/38
Study First Received: February 29, 2012
Last Updated: March 6, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013