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Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02477033
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, KU Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Butyricicoccus pullicaecorum 25-3T Other: Maltodextrin Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Placebo-controlled Cross-over Randomized Study to Investigate the Impact of Butyricicoccus Pullicaecorum in Healthy Human Volunteers
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Active Comparator: Butyricicoccus pullicaecorum
Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating.
Dietary Supplement: Butyricicoccus pullicaecorum 25-3T
Other Name: LMG 24109T; CCUG 55265T

Placebo Comparator: Placebo (maltodextrin)
Lyophilized maltodextrin, encapsulated with a pH-resistent coating.
Other: Maltodextrin



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities [ Time Frame: 1 year ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

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): NCT02477033


Locations
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Belgium
KULeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
KU Leuven

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Responsible Party: Kristin Verbeke, Professor Kristin Verbeke, KU Leuven
ClinicalTrials.gov Identifier: NCT02477033     History of Changes
Other Study ID Numbers: ML9449
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015