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| ID | Type | Description | Link |
|---|---|---|---|
| ECM4(i)11/12/2025 | Other Identifier | Clinical Research Ethics Committee of the Cork Teaching Hospitals |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Active Comparator | Synbiotic dietary supplement |
|
| Placebo | Placebo Comparator | Identical looking placebo consisting of maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement | Synbiotic - Given daily for 56 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bifidobacterium abundance | Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing. | From baseline to end of intervention at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Change in number of daily bowel movements from 2 weeks average prior to baseline to 2 weeks average prior to end of intervention. An increase is desirable. | From baseline to end of intervention at 8 weeks |
| Fecal acetate |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of probiotic strains | Recovery and colonization of strains by strain specific qPCR of fecal samples | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| Total relative abundance of Bifidobacterium |
Inclusion Criteria:
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-IBS composite symptom score between 20-45 during the two-week run-in period Record ≤6 bowel movements in the daily diary during the two-week run-in period
Exclusion Criteria:
Has a history of drug and/or alcohol abuse.
Has food allergies, or other issues with foods, that would preclude intake of the study products.
Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
c. immunosuppressant drugs within the 4 weeks prior to the visit 1 d. systemic steroids within the 4 weeks prior to the visit 1 6. Regular oral non-steroidal anti-inflammatory (NSAIDs) within 1 week prior to visit 1 (topical NSAIDS allowed, Low-dose prophylactic aspirin use is acceptable if stable for 3 months prior to screening.) 7. Current or recent (in the past 4 weeks prior to visit 1) use of prohibited nutritional and non-nutritional supplements, that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, including:
a. Herbal supplements for digestive symptoms b. Large doses of vitamins and minerals, unless in stable dose c. Probiotic supplements d. Iron supplements 8. Current or recent (in the past 2-weeks) use of prohibited foods including yoghurts containing probiotics.
9. Planned major changes in lifestyle [i.e., diet (e.g. start of fibre-enriched diet), dieting, exercise level, travelling] during the duration of the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Engel, PhD | Contact | +45 45 74 74 74 | saen@novonesis.com | |
| Emma Harrington | Contact | eharrington@atlantiatrials.com |
| Name | Affiliation | Role |
|---|---|---|
| Timothy G Dinan, Professor | Atlantia Clinical Trials Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials Ltd | Recruiting | Cork | Blackpool | T23 R50R | Ireland |
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A randomized, double-blind, placebo-controlled trial of 8-week intervention and a 2-week follow-up period in a group of middle-aged to elderly adults with GI discomfort
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Quardrople
| Placebo |
| Dietary Supplement |
Placebo - Given daily for 56 days |
|
Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
| From baseline to end of intervention at 8 weeks. |
| Fecal propionate | Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. | From baseline to end of intervention at 8 weeks. |
| Fecal butyrate | Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. | From baseline to end of intervention at 8 weeks |
| Zonulin | Change in serum zonulin from baseline to 8 weeks | From baseline to end of intervention at 8 weeks |
| Lipopolysaccharide binding protein (LPS-BP) | Change in plasma LPS-BP from baseline to 8 weeks | From baseline to end of intervention at 8 weeks |
| Interleukin 6 (IL-6) | Change in serum IL-6 from baseline to 8 weeks | From baseline to end of intervention at 8 weeks |
| High-sensitivity C-Reactive Protein (hsCRP) | Change in serum hsCRP from baseline to 8 weeks. | From baseline to end of intervention at 8 weeks |
| Fecal Short-Chain Fatty Acids (SCFA) | Change in composite measurement of fecal SCFAs panel with targeted metabolomics (GC-MSMS) from baseline to 8 weeks. Total composite is defined as: acetate + propionate + butyrate. | From baseline to end of intervention at 8 weeks |
| Stool consistency | Change in mean stool consistency assessed daily from 2 weeks prior to baseline to daily 2 weeks prior to end-of intervention. Stool consistency will be assessed by Bristol stool chart scale rated Type 1 (separate hard lumps) to Type 7 (watery, no solid pieces). An increase in stool consistency is desirable. | From baseline to end of intervention at 8 weeks |
| Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score | Change in GSRS-IBS composite score from baseline to end-of-intervention visit. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable. | From baseline to end of intervention at 8 weeks |
Change in total relative abundance of Bifidobacterium after 2 weeks of follow-up (no intervention) compared to effect after 3 weeks and 8 weeks of intervention.
| Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up. |
| Microbiome composition and taxonomic profiles | Changes in gut microbiome composition and taxonomic profiling analyzed by shotgun metagenomic sequencing of fecal samples | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| Microbiome functional profiling | Change in gut microbiome functional profiling analyzed by shotgun metagenomic sequencing of fecal samples | Basline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| Plasma Metabolomics | Change in blood metabolome as assessed by untargeted and targeted metabolomics from plasma samples | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| Fecal metabolomics | Change in fecal metabolome as assessed by untargeted and targeted metabolomics from fecal samples | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| Bacterial HMO utilization genes | Abundance development over time of HMO degradation and modification genes such as Glycosyl hydrolases, encoded by probiotic supplements and endogenous gut species | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| HMO concentration in blood and feces | Change in HMO in plasma and fecal samples after 3 and 8 weeks of supplementation | Baseline, 3 weeks and end of intervention at 8 weeks |
| Fecal pH | Change in pH assessed using a pH meter in fecal samples | Baseline, 3 weeks and end of intervention at 8 weeks |
| Inflammatory Biomarkers | Change in inflammatory biomarkers measured in serum | Baseline, 3 weeks and end of intervention at 8 weeks |
| Cardiometabolic Biomarkers | Change in cardiometabolic biomarkers | Baseline, 3 weeks and end of intervention at 8 weeks |
| Cognitive function measured by the Trails Making Test (Parts A & B) | Change in cognitive function assessed using Trail Making Test (Parts A & B) | Baseline and end of intervention at 8 weeks |
| Cognitive function measured by the Stroop Colour and Word Test | Change in cognitive function assessed using the Stroop Colour and Word Test | Baseline and end of intervention at 8 weeks |
| Cognitive function measured by the Symbol Digit Modalities Test (SDMT) | Change in cognitive function assessed using the Symbol Digit Modalities Test (SDMT) | Baseline and end of intervention at 8 weeks |
| Health-related Quality of Life | Change in health-related quality of life assessed by Short Form-36 (RAND SF-36) | Baseline, 3 weeks and end of intervention at 8 weeks |
| Gastrointestinal Symptoms Measured by the GSRS-IBS Total Score | Change in gastrointestinal symptoms by assessing the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS). The outcome reflects the total composite score. A decrease is desirable. | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up |
| GSRS-IBS Pain Subscale | Change in the gastrointestinal symptom pain assessed using GSRS-IBS subscale for Pain. A decrease is desirable. | Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up. |
| GSRS-IBS Bloating Subscale | Change in the gastrointestinal symptom bloating assessed using GSRS-IBS subscale for bloating. A decrease is desirable. | Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up |
| GSRS-IBS Constipation Subscale | Change in the gastrointestinal symptom constipation assessed using GSRS-IBS subscale for constipation. A decrease is desirable | Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up |
| GSRS-IBS Diarrhea Subscale | Change in the gastrointestinal symptom Diarrhea assessed using GSRS-IBS subscale for Diarrhea. A decrease is desirable. | Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up |
| GSRS-IBS Early Satiety Subscale | Change in the gastrointestinal symptom early satiety assessed using GSRS-IBS subscale for early satiety. | Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up |
| Protein Composite Score | Change in protein composite score measured using OLINK Reveal panel | Baseline, 3 weeks and end of intervention at 8 weeks |
| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |
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