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

NCT01545219 | Completed

• 1 other identifier: 08/38
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Microbiota; Bowel Function; Immune Function; Plasma Lipids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Bowel function, immune function and plasma lipids

  7 months

Study Arms (4)

Prebiotic

EXPERIMENTAL

Dietary Supplement: Prebiotic

Probiotic

EXPERIMENTAL

Dietary Supplement: Bi-07

Synbiotic

EXPERIMENTAL

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Prebiotic DIETARY_SUPPLEMENT

8g/day xylo-oligosaccharide

Prebiotic

Bi-07 DIETARY_SUPPLEMENT

10\^9 CFU B. lactis / day

Probiotic

Synbiotic DIETARY_SUPPLEMENT

8g/day xylo-oligosaccharide + 10\^9 CFU Bi-07

Synbiotic

Placebo DIETARY_SUPPLEMENT

8g/day maltodextrin

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed consent form
• age 25-65 years
• body mass index 20-30 inclusive
• good general health as determined by medical questionnaires

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Danisco: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Interventions

Prebiotics; Synbiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Probiotics

Study Officials

• Glenn R Gibson, BSc, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral research fellow

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

GB (1)