Within the framework of the Science Foundation Ireland funded Microbe Restore Project, the Symbiont Restore Study is an Investigator-initiated trial which explores the prospective health advantages associated with a particular bacterium known as Limosilactobacillus reuteri (L. reuteri) PB-W1™. In the Symbiont Restore Study, we seek to determine if supplementation with L. reuteri PB-W1™, can beneficially alter the composition and function of the gut microbiome, particularly in terms of immunomodulatory benefits, intestinal health, satiety, as well as markers of psychological stress and sleep quality. Additionally, this study will explore whether combining this strain with a prebiotic blend of dietary fibres (comprising 50 % raffinose and 50 % xylooligosaccharide) through a "synbiotic" approach can enhance its therapeutic benefits.
Our preliminary work has shown that the gut microbiome in rural Papua New Guinea (PNG) is more diverse than that of USA controls, and the species Limosilactobacillus reuteri (L. reuteri) was only detectable in PNG. Interestingly, L. reuteri was also regularly detected in humans in studies conducted around 1960, but is very rarely found in contemporary humans, suggesting a recent decline of the L. reuteri population in Westerners. L. reuteri is further convincingly linked to a wide range of health benefits, such as modulating immune function and stimulating immune cell development, and it produces tryptophan metabolites that modulate the immune system. These findings provide a clear rationale to test the immunological effects of a L. reuteri strain that originates from PNG and explore nutritional strategies to potentially enhance these effects by supporting the colonisation of this strain. The main objective of this study is to systematically compare the possible immunological effects of synbiotic supplementation with a probiotic, L. reuteri PB-W1™, and a prebiotic blend (comprising 50 % raffinose and 50 % xylooligosaccharide) with that of the probiotic and prebiotic alone and characterise the mechanistic and ecological foundations of any effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
137
Participants in this arm will consume one probiotic capsule (L. reuteri PB-W1™) daily and placebo sachets three times daily (morning, midday, and evening) for a total daily dose of 7.5 g throughout the eight-week intervention period.
Participants in this arm will consume one placebo capsule daily and prebiotic sachets (Prebiotic Blend) three times daily (morning, midday, and evening) for a total daily dose of 15 g throughout the eight-week intervention period.
Participants in this arm will consume one probiotic capsule (L. reuteri PB-W1™) daily and prebiotic sachets (Prebiotic Blend) three times daily (morning, midday, and evening) for a total daily dose of 15 g throughout the eight-week intervention period.
Participants in this arm will consume one placebo capsule daily and placebo sachets three times daily (morning, midday, and evening) for a total daily dose of 7.5 g throughout the eight-week intervention period.
University College Cork
Cork, Cork, Ireland
Change from Baseline Immune Profile at 8 Weeks
Change from baseline serum cytokine concentrations measured using established methods and immune cell response determined through stimulation assays on peripheral blood mononuclear cells at 8 weeks.
Time frame: The assessments will be conducted at baseline (pre-intervention) and at the end of the eight-week intervention period.
Change from Baseline Faecal Microbiome Composition and Diversity at 8 Weeks
Change from baseline gut microbiota composition and diversity at eight weeks, through 16S rRNA gene sequencing of faecal samples.
Time frame: The assessments will be conducted at baseline (pre-intervention) and at the end of the eight-week intervention period.
Change from Baseline Metabolic Profile at 8 Weeks
Change from baseline faecal, serum, and urinary metabolite concentrations determined through liquid chromatography-mass spectrometry (LC-MS) at eight weeks.
Time frame: The assessments will be conducted at baseline (pre-intervention) and at the end of the eight-week intervention period.
Change from Baseline Satiety Rating over 8 Week Intervention
Change from baseline satiety rating over 8 week intervention period, through analysis of Participant responses to the Satiety Labelled Intensity Magnitude (SLIM) scale.
Time frame: Throughout the eight-week intervention period, assessed at specific time points (i.e., weekly) during the study.
Gastrointestinal Tolerance to Dietary Fibre
Evaluation of the impact of L. reuteri PB-W1™ supplementation with and without a prebiotic blend on gastrointestinal tolerance to dietary fibres (specifically, the prebiotic blend of 50 % raffinose and 50 % xylooligosaccharide) through monitoring of gastrointestinal symptoms and adverse events.
Time frame: Throughout the eight-week intervention period, assessed at specific time points (i.e., weekly) during the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.