Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Conditions
Keywords
Gastrointestinal Microbiome, Synbiotic
Brief 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.
Interventions
DIETARY_SUPPLEMENTSynbiotic
Synbiotic \- Given daily for 56 days
DIETARY_SUPPLEMENTPlacebo
Placebo \- Given daily for 56 days
Sponsors
Chr Hansen - part of Novonesis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quardrople
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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-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
1. Has a history of drug and/or alcohol abuse. 2. Has food allergies, or other issues with foods, that would preclude intake of the study products. 3. Smoking, chewable tobacco and/or vaping and/or use of other nicotine products. 4. 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: 1. diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS) 2. GI surgery that might have an effect on gastrointestinal tract function except cholecystectomy and appendectomy in the past 5 years or any major bowel resection at any time. 3. history of CVD 4. uncontrolled hypertension 5. 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: 1. systemic antimicrobial medication (including suppositories) within 4 weeks prior to visit 1 2. OTC medications, for digestive symptoms such as PPIs, anti-spasmodics, laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bifidobacterium abundance | From baseline to end of intervention at 8 weeks | Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency | From baseline to end of intervention at 8 weeks | 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. |
| Fecal acetate | From baseline to end of intervention at 8 weeks. | Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. |
| Fecal propionate | From baseline to end of intervention at 8 weeks. | Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. |
| Fecal butyrate | From baseline to end of intervention at 8 weeks | Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. |
| Zonulin | From baseline to end of intervention at 8 weeks | Change in serum zonulin from baseline to 8 weeks |
| Lipopolysaccharide binding protein (LPS-BP) | From baseline to end of intervention at 8 weeks | Change in plasma LPS-BP from baseline to 8 weeks |
| Interleukin 6 (IL-6) | From baseline to end of intervention at 8 weeks | Change in serum IL-6 from baseline to 8 weeks |
| High-sensitivity C-Reactive Protein (hsCRP) | From baseline to end of intervention at 8 weeks | Change in serum hsCRP from baseline to 8 weeks. |
| Fecal Short-Chain Fatty Acids (SCFA) | From baseline to end of intervention at 8 weeks | 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. |
| Stool consistency | From baseline to end of intervention at 8 weeks | 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. |
| Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score | From baseline to end of intervention at 8 weeks | 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. |
Countries
Ireland
Contacts
CONTACTSara Engel, PhD
CONTACTEmma Harrington
PRINCIPAL_INVESTIGATORTimothy G Dinan, Professor
Atlantia Clinical Trials Ltd
Outcome results
None listed