The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.

September 15, 2023 updated by: Oluf Pedersen

An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults

A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

By analyzing blood samples, indirect calorimetric as well as thermographic assessment of clavicular temperature we want to investigate whether or not the commensal gut bacterium Ruminococcus toqrues strain ATCC 27756 has any metabolic effects in healthy adults. The subjects will recieve the intervention with the live bacterium given through a duodenal feeding tube. The trial is double blinded and placebo controlled using a crossover design. Subjects will be given an intervention with either placebo or Ruminococcus on two different study days with up to six weeks of wash-out between each study day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Oluf B Pedersen, Prof, MD
  • Phone Number: +4529382526
  • Email: oluf@sund.ku.dk

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 40 years
  • Self-reported good health
  • Caucasian
  • Body Mass Index > 27 kg/m^2

Exclusion Criteria:

  • Any known disorder/disease that could interfere with study results or is seen as compromising to the study (as assessed by the investigator), for example diabetes, cancer or cardiovascular or kidney disease.
  • Use of any daily medication as well as p.r.n. (pro re nata; not taken regularly) medication that cannot be discontinued during the trial
  • Use of antibiotics during the recent three months
  • Acute or chronic gastrointestinal symptoms
  • Lactose intolerance
  • Pregnancy - ongoing or planned
  • Smoking
  • Alcohol or drug abuse
  • Use of creatine as dietary supplement during study period
  • Plasma creatinine above the normal range (>105 μmol/L for men and >90 μmol/L for women)
  • Known significant liver disease or plasma alanine transaminase concentration ≥ 3 × normal value
  • Values for hemoglobin, leukocytes, or thrombocytes outside of the normal ranges

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
Biological: Placebo
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
Experimental: Ruminococcus torques
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
Biological: Ruminococcus torques
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Matsuda Insulin Sensitivity Index
Time Frame: During two hours following a standard glucose solution (75g glucose in 250 ml of water) after the second dose of Ruminococcus or placebo has been given during the study day (second measurement up to six weeks later)
Differences in calculated Matsuda Insulin Sensitivity Index between the two study days
During two hours following a standard glucose solution (75g glucose in 250 ml of water) after the second dose of Ruminococcus or placebo has been given during the study day (second measurement up to six weeks later)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting energy expenditure
Time Frame: Three times during the study day for 15 minutes
Difference in resting energy expenditure measured by indirect calorimetric
Three times during the study day for 15 minutes
Activation of brown adipose tissue
Time Frame: 15 minutes 3 times during each study day
Difference in temperature measured with thermographic camera of the collar bones
15 minutes 3 times during each study day
Ruminococcus Irisin-Like Peptide (RUCILP)
Time Frame: During the six hours of the study day (up to six weeks between study days)
Differences in plasma RUCILP concentration between the two study days
During the six hours of the study day (up to six weeks between study days)
Glucose profile
Time Frame: During the six hours of the study day (up to six weeks between study days)
Difference in blood glucose profile during the entirety of the study day
During the six hours of the study day (up to six weeks between study days)
Bone dynamics
Time Frame: During the six hours of the study day (up to six weeks between study days)
Differences in measures of biomarkers of bone turnover in blood
During the six hours of the study day (up to six weeks between study days)
Gut microbiota
Time Frame: Samples taken prior to each visit (experimental days and follow-up visits)
Changes in gut microbiota composition after each intervention
Samples taken prior to each visit (experimental days and follow-up visits)
Metabolome
Time Frame: During the six hours of the study day (up to six weeks between study days)
Changes is plasma metabolome after intervention
During the six hours of the study day (up to six weeks between study days)
Peptide YY
Time Frame: During the six hours of the study day (up to six weeks between study days)
Differences in plasma Peptide YY concentration between the two study days
During the six hours of the study day (up to six weeks between study days)
Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1
Time Frame: During the six hours of the study day (up to six weeks between study days)
Differences in area under the curve between the two study days
During the six hours of the study day (up to six weeks between study days)
Cytokine profile
Time Frame: During the six hours of the study day
Differences in the cytokine profiles during the study day
During the six hours of the study day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: During the six hours of the study day (up to six weeks between study days)
Changes in heart rate during study day
During the six hours of the study day (up to six weeks between study days)
Blood pressure
Time Frame: During the six hours of the study day (up to six weeks between study days)
Changes in blood pressure during study day
During the six hours of the study day (up to six weeks between study days)
Various hormones related to metabolism
Time Frame: During the six hours of the study day (up to six weeks between study days)
Differences in measures of various hormones during the study day
During the six hours of the study day (up to six weeks between study days)
Standard hematologic blood samples
Time Frame: During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
Differences in measures of standard hematologic biomarkers in the blood, such as platelets
During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
Standard clinical biochemical variables
Time Frame: During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
Differences in measurements of standard clinical biochemical biomarkers, such as alanine transaminase and creatinine
During the six hours of the study day (up to six weeks between study days) as well as one week after each study day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oluf Pedersen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
University Hospital, Gentofte, Copenhagen
Technical University of Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oluf B Pedersen, Prof, MD, Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-21075670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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