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Efficacy and Safety of Probiotic Products for Digestive Health

Efficacy and Safety of Probiotic Products for Digestive Health

Recruiting
18-60 years
All
Phase N/A

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Overview

The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.

Eligibility

Inclusion Criteria:

  1. Male or Female subject age 18-60 years at screening
  2. Healthy subject according to investigator judgement based on screening data
  3. Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study
  4. Subjects who have not smoked in the past 1 month prior to screening
  5. Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption
  6. Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol
  7. Signed informed consent from the subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)

Exclusion Criteria:

  1. History of presence of diabetes, immunodeficiency disorders, or chronic illness
  2. Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants
  3. Have continuous, daily use of probiotic or probiotic containing products within 1 month prior to randomization
  4. Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening)
  5. Change type of diet during study
  6. Any known allergy or intolerance to any of the ingredients in the formulation of the product under study
  7. History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study
  8. History of or presence of eating disorder
  9. Subject whose condition does not make them eligible to the study, according to the investigator

Study details
    Healthy Adult

NCT06385639

Wecare Probiotics Co., Ltd.

1 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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