NCT05942586

The Symbiont-Restore Study

Systematic Functional Characterization of the Effect of Synbiotic Supplementation with Limosilactobacillus Reuteri PB-W1™ and Prebiotics on Markers of Immune Health, Host Metabolome and Gut Microbiome in Adults with BMI 30-40 Kg/m²

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic capsule (L. reuteri PB-W1™), Placebo sachet	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.
DIETARY_SUPPLEMENT	Prebiotic sachet (Prebiotic Blend), Placebo capsule	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.
COMBINATION_PRODUCT	Probiotic capsule (L. reuteri PB-W1™), Prebiotic sachet (Prebiotic Blend)	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.
DIETARY_SUPPLEMENT	Placebo sachet, Placebo capsule	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.

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2023-07-12
• Last updated: 2025-02-10

Locations

1 site across 1 country: Ireland