The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Midd
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
| Condition(s) | Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Be able to give informed consent. 2. Be between 50 to 70 years of age (inclusive). 3. BMI ranging from 25.0 and 35.0 kg/m² 4. Willing to maintain current level of physical activity and diet during the participation in the study. 5. Experience ≤3 bowel movements per week within the month prior to screening 6. Participants reported subclinical mild to moderate gastrointestinal complaints as defined by GSRS-IBS score 20-45 at screening. 7. Willing to consume the study product daily for the duration of the study. 8. Willing to eat the same meal the evening before visiting site (visit 2 to visit 5). Participants are eligible for randomization if they fulfill the following two criteria based on the diary recordings during the run-in period prior to visit 2 9. Average GSRS- |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Chr Hansen - part of Novonesis |
| Locations | Cork, Blackpool, Ireland |
| Start date | 2026-03-18 |
| NCT ID | NCT07453823 |
| Official listing | https://clinicaltrials.gov/study/NCT07453823 |