Obesity Clinical Trial - The Symbiont-Restore Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Obesity

Clinical Trial Details

NCT number	NCT05942586
Study type	Interventional
Source	University College Cork
Contact	Victoria McMahon
Phone	+353 (0)86-127-4588
Email	probioticstudy@ucc.ie
Status	Recruiting
Phase	N/A
Start date	May 22, 2023
Completion date	May 10, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.