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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriella C. van Zanten, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01716910
First received: October 18, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Synbiotics
Healthy Humans
Composition of Gut Microbiota
Short and Branched-chain Fatty Acids
Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose
Phase 0

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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • increase in fecal butyrate concentration [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in composition of microbiota [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • changes in short-chain fatty acids [ Time Frame: 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) ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Maltodextrin
'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day
Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose
Active Comparator: Synbiotic
'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU
Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:healthy individuals between 18-50 years of age who had not used antibiotics three months prior to the trial

-

Exclusion Criteria:

  • chronic illness
  • regular intake of medication (except birth-control pills)
  • post-menopausal women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716910

Locations
Denmark
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Gabriella C. van Zanten, PhD student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01716910     History of Changes
Other Study ID Numbers: DK-H-4-2010-137
Study First Received: October 18, 2012
Last Updated: October 29, 2012
Health Authority: Denmark: Scientific Ethics Committee of Capital Region of Denmark

ClinicalTrials.gov processed this record on October 23, 2014