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

NCT ID: NCT01716910

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Maltodextrin

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

Group Type PLACEBO_COMPARATOR

Combination of Lactobacillus acidophilus NCFM and cellobiose

Intervention Type DIETARY_SUPPLEMENT

Synbiotic

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

Group Type ACTIVE_COMPARATOR

Combination of Lactobacillus acidophilus NCFM and cellobiose

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Combination of Lactobacillus acidophilus NCFM and cellobiose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* chronic illness
* regular intake of medication (except birth-control pills)
* post-menopausal women
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Gabriella C. van Zanten

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriella C. van Zanten, PhD student

Role: PRINCIPAL_INVESTIGATOR

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

Gabriella C van Zanten, PhD student

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Frederiksberg C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DK-H-4-2010-137

Identifier Type: -

Identifier Source: org_study_id