Efficacy and Safety of Probiotic Products for Digestive Health

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult
• Intervention / Treatment: Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danang A. Yunaidi, MD; Phone Number: ＋62 021 7515932; Email: danang@equilab-int.com

Study Locations

• Indonesia
  • Pusat
    • Jakarta, Pusat, Indonesia, 10430
      • Recruiting
      • Danang@Equilab-Int.Com
      • Contact: Danang A. Yunaidi, MD; Phone Number: +62 217515932; Email: danang@equilab-int.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Group; Two sachets/day probiotics, before breakfast and dinner, respecitvely	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).
Placebo Comparator: Placebo Group; Maltodextrin, Two sachets/day probiotics, before breakfast and dinner, respecitvely	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal health	Changes in short-chain fatty acid (SCFA) from baseline to day 10	10 days

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2024
• Primary Completion (Estimated): May 25, 2024
• Study Completion (Estimated): June 25, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WK2024005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No