The Symbiont-Restore Study

Last updated: February 6, 2025
Sponsor: University College Cork
Overall Status: Completed

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Prebiotic sachet (Prebiotic Blend), Placebo capsule

Placebo sachet, Placebo capsule

Probiotic capsule (L. reuteri PB-W1™), Prebiotic sachet (Prebiotic Blend)

Clinical Study ID

NCT05942586
APC165
  • Ages 18-55
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • To be considered eligible for enrolment into the study, potential Participants must:

  • Be able to give written informed consent.

  • Be between 18 and 55 years of age.

  • Self-identify as White.

  • Have a BMI of 30-40 kg/m2 and waist circumference of ≥102cm (males) or ≥88cm (females).

  • Have a stable body weight (≤5% change) over the past three months.

  • Be in general good health, as determined by interview and having systolic bloodpressure less than 160 mm Hg and diastolic blood pressure less than 100 mm Hg (defined as hypertension stage 2), taken by the investigator.

  • Be willing to avoid consuming dietary supplements, prebiotics, probiotics, orfibre-rich supplements within four weeks prior to the baseline visit and untilthe end of the study.

  • Be willing to maintain their current level of physical activity.

  • Be willing to consume the investigational product daily for the duration of thestudy.

  • Be willing to maintain their habitual diet for the duration of the study.

Exclusion

Exclusion Criteria:

  • Potential Participants will be excluded from the study if they meet any of the belowcriteria:

  • Are pregnant, lactating or post-menopausal or women who are planning to becomepregnant over the study period.

  • Have hypersensitivity, allergy, or intolerance to any of the components of theinvestigational products.

  • Have received antibiotic treatment within three months prior to baseline.

  • Are taking a medication that the investigator believes would interfere with theobjectives of the study, pose a safety risk, or confound the interpretation ofthe study results. Participants should have a wash-out period of two-weeks foreach of these medications except for antibiotics, which should not have beentaken in the previous three months. Participants taking proton pump inhibitorswill be allowed into the study if the dose has been stable for at least twomonths prior to baseline. Similarly, occasional use of over-the-counternon-steroidal analgesics may be acceptable (at the discretion of the ChiefInvestigator). However, participants will be required to note any medicationsconsumed via the Medical History, Medications and Supplements Log (MR2006).

  • Have a history or indication of drug and/or alcohol abuse at the time ofenrolment.

  • Have a significant active and medically diagnosed acute or chronic co-existingillness including metabolic, psychiatric, or gastrointestinal disease (such asdiarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach orduodenal ulcers, hepatitis A/B/C, HIV, cancer etc.). Participants that have asignificant family history of such diseases or any other condition whichcontraindicates, in the investigator's judgement, entry to the study will alsobe excluded.

  • Habitual consumption of >2 alcoholic beverages/day (>28g ethanol/day).

  • Are vegetarian or vegan, those with a typical fibre intake of >30g/day andthose that have used dietary supplements (prebiotics/probiotics) in the monthleading up to the study.

  • Have made major dietary changes within three months prior to baseline and thosewith major lifestyle changes planned during the study (e.g., diet, exercise,extensive travel etc).

  • Those with clinically diagnosed eating disorders.

  • Have active gastrointestinal disorder or previous gastrointestinal surgery.

  • Have a chronic medication treatment (e.g., anti-hypertensive medications) ofunstable dosage, defined as having been changed within two months prior tobaseline.

  • Are severely immunocompromised (HIV positive, transplant recipients, on anyanti-rejection medications, on a systemic-acting steroid for >30 days, or havehad chemotherapy or radiotherapy in the last 12 months.

  • Have a malignant disease or any concomitant end-stage organ disease.

  • Have symptomatic illness, that in the opinion of the Investigator,contraindicates entry onto the study.

  • Experienced alarm features such as unexplained weight loss, rectal bleeding, arecent change in bowel habits, or significant abdominal pain within threemonths prior to baseline.

  • Individuals who, in the opinion of the investigator, are considered to be poorattendees or unlikely for any reason to be able to comply with the trial.

  • Participants may not be receiving treatment involving experimental drugs.

  • If the Participant has been in a recent experimental trial, these must havebeen completed not less than 30 days prior to this study.

  • Any Participant that regularly undertakes rigorous exercise defined byInternational Physical Activity Questionnaire with a score within category 3,Health Enhancing Physical Activity (HEPA) Active.

  • Individuals with pacemakers or implantable cardioverter defibrillators.

Study Design

Total Participants: 137
Treatment Group(s): 4
Primary Treatment: Prebiotic sachet (Prebiotic Blend), Placebo capsule
Phase:
Study Start date:
May 22, 2023
Estimated Completion Date:
December 04, 2024

Study 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.

Connect with a study center

  • University College Cork

    Cork,
    Ireland

    Site Not Available

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