SynbioticsEarly Phase 1NCT01716910
Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids
A Early Phase 1 study testing Combination of Lactobacillus acidophilus NCFM and cellobiose in people with Synbiotics and Healthy Humans, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Synbiotics, Healthy Humans, Composition of Gut Microbiota
- What is being tested?
- Combination of Lactobacillus acidophilus NCFM and cellobiose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jun 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- chronic illness
- regular intake of medication (except birth-control pills)
- post-menopausal women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Frederiksberg C, 1958
About this study
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
- Being tested
- Combination of Lactobacillus acidophilus NCFM and cellobiose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Lactobacillus acidophilus NCFM and cellobioseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | 'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day Receives: 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 Receives: Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in fecal butyrate concentration
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynbioticsStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriella C. van Zanten, University of Copenhagen
- Investigators
- Gabriella C. van Zanten, PhD student, Principal investigator, Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, DenmarkGabriella C van Zanten, PhD student, Principal investigator, Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716910
- Sponsor's protocol ID
- DK-H-4-2010-137
- Status last verified
- Oct 2012
- First submitted
- 18 Oct 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids
- ClinicalTrials.gov ID
- NCT01716910
- Acronym / sponsor ID
- DK-H-4-2010-137
- Conditions
- Synbiotics, Healthy Humans, Composition of Gut Microbiota, Short and Branched-chain Fatty Acids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day |
| Synbiotic | Active comparator | Dietary Supplement: Combination of Lactobacillus acidophilus NCFM and cellobiose'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- chronic illness
- regular intake of medication (except birth-control pills)
- post-menopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of Lactobacillus acidophilus NCFM and cellobiose | Dietary supplement | Maltodextrin, Synbiotic |
Primary outcome
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)
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
Related trials for Synbiotics
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Recruiting
Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.
Chronic Kidney Disease (Stage 3-4)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
Follow-on Formula, Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella C. van Zanten, PhD student principal investigator
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
Gabriella C van Zanten, PhD student principal investigator
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Combination of Lactobacillus acidophilus NCFM and cellobiose in people with Synbiotics and Healthy Humans, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.