The Symbiont-Restore Study

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.

Conditions

• Obesity

Interventions

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.

Sponsors & Collaborators

• Novozymes A/S

  collaborator INDUSTRY

• University College Cork

  lead OTHER

Principal Investigators

• Jens Walter · University College Cork

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-22

Primary Completion

2024-12-04

Completion

2024-12-04

Countries

• Ireland

Study Locations