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

NCT ID: NCT05448274

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2023-09-14

Brief Summary

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

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.

Conditions

Overweight; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

Ruminococcus torques

10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Group Type: EXPERIMENTAL

Ruminococcus torques

Intervention Type: BIOLOGICAL

10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Interventions

Placebo

The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

Intervention Type: BIOLOGICAL

Ruminococcus torques

10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Technical University of Denmark

OTHER

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: collaborator

Oluf Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Oluf Pedersen

Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oluf B Pedersen, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Locations

Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-21075670

Identifier Type: -

Identifier Source: org_study_id