Tolerability and Risk of Adverse Events With a Probiotic Supplement
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel
      and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced
      presence of it has been associated with an imbalance in the gastrointestinal flora of
      metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease.

      The present double-blind, placebo-controlled, randomized study is designed to investigate if
      dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8
      consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a
      positive way.
    

Detailed description: 
      The understanding of the role of the gastrointestinal microbes for human health has gained
      considerable interest in recent years. The butyrate-producing bacterium Faecalibacterium
      prausnitzii is a naturally occurring bacterial species in the human gut that can make up to
      5% of the gastrointestinal flora in healthy individuals.

      Several studies have shown that the presence of butyrate producing bacteria, including F.
      prausnitzii, is lower in patients with inflammatory bowel disease; Crohn's disease and
      ulcerative colitis. Furthermore, lower levels of short fatty acids have been found in people
      with ulcerative colitis as compared to healthy individuals. Similar results have been
      obtained from studies about Crohn's disease, where people with a low abundance of F.
      prausnitzii run a higher risk of post-operative recurrence of their disease.

      It has become evident that bacteria in the human gastrointestinal tract are symbiotic and
      dependent on each other's metabolism. Studies conducted by the sponsor (Metabogen AB) have
      shown that butyrate production from F. prausnitzii increases in the presence of Desulfovibrio
      piger, a common sulphate-reducing bacterium present in the human intestine. The symbiotic
      relationship between F. prausnitzii and D. piger can be utilised by combining these bacterial
      species into a probiotic dietary supplement, thus maintaining butyrate production in the
      intestine.

      In animal models, who received approximately 5,000 times higher doses per kilogram of body
      weight than the highest dose scheduled in the proposed study, the intake of F. prausnitzii
      has shown anti-inflammatory effects as well as positive effects on the metabolism.

      The present study is a double-blind, placebo-controlled, randomized, study in 48 healthy
      individuals (men and women) between 20 and 40 years old recruited from the general
      population. These volunteers will either receive F. prausnitzii and D. piger (in two
      different doses) or placebo orally once a day for 8 consecutive weeks. The investigators will
      assess how well treatment with the study product compared to placebo is tolerated
      (termination due to adverse events within 8 weeks of treatment) and if it can cause
      gastrointestinal symptoms (measured with The Gastrointestinal Symptom Rating Scale). The
      investigators will also assess if the intake of the study product can potentially give
      positive effects in the metabolism (blood glucose, fatty acids, protein ect).
    

Intervention name(s): Placebo; High dose F. prausnitzii and D. piger; Low dose F. prausnitzii and D. piger
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplementation with placebo once a day for 8 consecutive weeks; Dietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks; Dietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Faecalibacterium prausnitzii; Desulfovibrio piger; tolerability; blood glucose levels