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The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight

NCT07453823 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-15

No results posted yet for this study

Summary

The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.

The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.

Conditions

  • Gastrointestinal Microbiome (Focus)
  • Gastrointestinal Symptoms

Interventions

DIETARY_SUPPLEMENT

Synbiotic

Synbiotic \- Given daily for 56 days

DIETARY_SUPPLEMENT

Placebo

Placebo \- Given daily for 56 days

Sponsors & Collaborators

  • Chr Hansen - part of Novonesis

    lead INDUSTRY

Principal Investigators

  • Timothy G Dinan, Professor · Atlantia Clinical Trials Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453823 on ClinicalTrials.gov