CompletedNCT02477033Updated Jun 22, 2015

Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

A Phase 1 interventional study of Butyricicoccus pullicaecorum 25-3T and Maltodextrin in Healthy, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-22.

Sponsored by KU Leuven · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.

Read the detailed description

Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.

Conditions studied

Healthy

In context

Lead sponsor

KU Leuven is the lead sponsor of 371 studies on the registry; 63 are open to participants now.

Browse KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

BMI between 18 and 28 kg/m²
Good general health
Regular eating pattern (3 meals/day on at least 5 days/week)

Exclusion criteria

Exclusion Criteria:

Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation or chronic diarrhea)
Surgery of the gastrointestinal tract (except for an appendectomy)
Use of antibiotics during the month preceding the study
Use of medication or dietary supplements influencing gut transit or intestinal microbiota during the month preceding the study. Examples of such medication/dietary supplements are antispasmodics (e.g. buscopan), antidiarrheal medication (e.g. imodium), probiotic medication (e.g. lacteol, enterol)
Intake of pre- or probiotics during the study or during the month preceding the study
Being on a weight-loss diet during the study or during the month preceding the study
Extreme dietary habits (e.g. vegan, Atkins diet, Montignac diet)
Females who are pregnant, lactating or planning to become pregnant during the study period

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Active comparator
Butyricicoccus pullicaecorum
Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating.
Dietary Supplement: Butyricicoccus pullicaecorum 25-3T
Placebo comparator
Placebo (maltodextrin)
Lyophilized maltodextrin, encapsulated with a pH-resistent coating.
Other: Maltodextrin

Interventions

Dietary supplementButyricicoccus pullicaecorum 25-3T
Also known as: LMG 24109T; CCUG 55265T
OtherMaltodextrin

What researchers measure

Primary outcomes

Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements
Time frame: 1 year

Secondary outcomes

The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities
Time frame: 1 year
The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds
Time frame: 1 year

Study locations

1 site

KULeuven
Leuven, Vlaams-Brabant 3000, Belgium

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Jun 2014 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 12, 2015
First posted: Jun 22, 2015
Start: Feb 2014
Primary completionActual: Jun 2014
CompletionActual: Feb 2015
Last update: Jun 22, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02477033
Lead sponsor: KU Leuven
Responsible party: Kristin Verbeke (Professor Kristin Verbeke, KU Leuven) — Principal investigator
First posted: Jun 22, 2015
Start date: Feb 2014
Primary completion: Jun 2014
Completion: Feb 2015
Last update: Jun 22, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

KU Leuven →

Start the discussion