Phase
Condition
Non-ulcer Dyspepsia (Nud)
Treatment
Synbiotic
Placebo
Clinical Study ID
Ages 50-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be able to give informed consent.
Be between 50 to 70 years of age (inclusive).
BMI ranging from 25.0 and 35.0 kg/m²
Willing to maintain current level of physical activity and diet during theparticipation in the study.
Experience ≤3 bowel movements per week within the month prior to screening
Participants reported subclinical mild to moderate gastrointestinal complaints asdefined by GSRS-IBS score 20-45 at screening.
Willing to consume the study product daily for the duration of the study.
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
Exclusion Criteria:
Has a history of drug and/or alcohol abuse.
Has food allergies, or other issues with foods, that would preclude intake of thestudy 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 preventthem from fulfilling the study requirements, put the Participant at risk or wouldconfound the interpretation of the study results as judged by the investigator onthe basis of medical history and routine laboratory test results. Excluded healthconditions include:
diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory boweldisease, colon cancer) or irritable bowel syndrome (IBS)
GI surgery that might have an effect on gastrointestinal tract function exceptcholecystectomy and appendectomy in the past 5 years or any major bowelresection at any time.
history of CVD
uncontrolled hypertension
Currently or recently taking a medication that the investigator believes wouldinterfere with the objectives of the study or pose a safety risk or confound theinterpretation of the study results. Prohibited medications include:
systemic antimicrobial medication (including suppositories) within 4 weeksprior to visit 1
OTC medications, for digestive symptoms such as PPIs, anti-spasmodics,laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1
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.
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.
- 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.
Study Design
Connect with a study center
Atlantia Clinical Trials Ltd
Cork, Blackpool T23 R50R
IrelandActive - Recruiting

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