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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716910
First Posted: October 30, 2012
Last Update Posted: October 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gabriella C. van Zanten, University of Copenhagen
  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 Early Phase 1

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

Resource links provided by NLM:


Further study details as provided by Gabriella C. van Zanten, 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) ]

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) ]
  • 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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 18, 2012
First Posted: October 30, 2012
Last Update Posted: October 30, 2012
Last Verified: October 2012