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

Oluf Pedersen

Status: Completed

Conditions: Healthy; Overweight

Treatments: Biological: Placebo; Biological: Ruminococcus torques

Study type: Interventional

Funder types: Other

Identifiers

NCT05448274

H-21075670

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

Ruminococcus torques

Experimental group

Description:

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

Treatment:

Biological: Ruminococcus torques