Clinical trial

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

Name

H-21075670

Description

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

Trial arms

Trial start

2023-05-03

Estimated PCD

2023-09-06

Trial end

2023-09-14

Status

Completed

Treatment

Placebo

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

Arms:

Placebo

Ruminococcus torques

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

Arms:

Ruminococcus torques

Size

Primary endpoint

Matsuda Insulin Sensitivity Index

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)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A crossover study where subjects recieve placebo or Ruminococcus torques on two different study days with three to six weeks of wash-out between the study days.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2023-09-21

1 organization

1 product

1 drug

2 indications

Organization

Drug

Indication

Indication

Product