Efficacy and Safety of Probiotic Products for Digestive Health

Healthy Adult Clinical Trial

Official title:

A Double-blind, Randomized Clinical Study, Compared With Placebo to Assess the Efficacy and Safety of a Probiotic Product Containing Four Probiotic Strains to Support Digestive Environment and Homeostasis of Gut Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385639
• Other study ID #: WK2024005
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: June 25, 2024

Study information

• Verified date: April 2024
• Source: Wecare Probiotics Co., Ltd.
• Contact: Danang A. Yunaidi, MD
• Phone: 021 7515932
• Email: danang[@]equilab-int.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

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

Related Conditions & MeSH terms

• Healthy Adult

Intervention

Dietary Supplement:
• Probiotic
This clinical trial will last for 10 days, and each subject will have 4 follow-up visits (Day -1, Day 0, Day 10, Day 20).

Locations

Country	Name	City	State
Indonesia	Danang@Equilab-Int.Com	Jakarta	Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal health	Changes in short-chain fatty acid (SCFA) from baseline to day 10	10 days