Efficacy and Safety of Probiotic Products for Digestive Health

Not Applicable

Recruiting

• Conditions: Healthy Adult
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT06385639
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study Start: 2024-04-25
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Primary Completion: 2024-05-25
• Study Completion: 2024-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Probiotic	Maltodextrin, Two sachets/day probiotics, before breakfast and dinner, respecitvely
Probiotic Group	Probiotic	Two sachets/day probiotics, before breakfast and dinner, respecitvely

Primary Outcome Measures

Name	Time	Method
Intestinal health	10 days	Changes in short-chain fatty acid (SCFA) from baseline to day 10

Trial Locations

Locations (1)

Danang@Equilab-Int.Com; 🇮🇩 Jakarta, Pusat, Indonesia