Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids

NCT01716910 | Completed Early Phase 1

• 1 other identifier: DK-H-4-2010-137
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week clinical trial on healthy volunteers. Following a two week run-in-period, subjects were randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a 3-week wash-out period before the second treatment period, followed by a another wash-out period. Volunteers completed questionnaires for each period on overall health and well being, stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to collect fecal samples for investigation of microbiological and microbial metabolites before and after three treatment periods. The primary objective of the study is tan increase in fecal butyrate concentration. Secondary objectives are changes in microbiota composition and short-chain fatty acids.

Conditions

Synbiotics; Healthy Humans; Composition of Gut Microbiota; Short and Branched-chain Fatty Acids

Outcome Measures

Primary Outcomes (1)

• increase in fecal butyrate concentration

  12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)

Secondary Outcomes (2)

• changes in composition of microbiota

  12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)

• changes in short-chain fatty acids

  12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)

Study Arms (2)

Maltodextrin

PLACEBO COMPARATOR

'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day

Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose

Synbiotic

ACTIVE COMPARATOR

'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU

Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose

Interventions

Combination of Lactobacillus acidophilus NCFM and cellobiose DIETARY_SUPPLEMENT

Maltodextrin; Synbiotic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• chronic illness
• regular intake of medication (except birth-control pills)
• post-menopausal women

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Interventions

Cellobiose

Intervention Hierarchy (Ancestors)

Cellulose; Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Gabriella C. van Zanten, PhD student

  Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Gabriella C van Zanten, PhD student

  Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• 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: PhD student

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 30, 2012
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

DK (1)