Efficacy and Safety of Probiotic Products for Digestive Health

NCT06385639 | Recruiting DMC

• 1 other identifier: WK2024005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (1)

• Intestinal health

  Changes in short-chain fatty acid (SCFA) from baseline to day 10

  10 days

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Two sachets/day probiotics, before breakfast and dinner, respecitvely

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

Maltodextrin, Two sachets/day probiotics, before breakfast and dinner, respecitvely

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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 Group; Probiotic Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female subject age 18-60 years at screening
• Healthy subject according to investigator judgement based on screening data
• 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
• Subjects who have not smoked in the past 1 month prior to screening
• Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption
• Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol
• Signed informed consent from the subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)

You may not qualify if:

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

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Danang@Equilab-Int.Com

Jakarta, Pusat, 10430, Indonesia

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Danang A. Yunaidi, MD

CONTACT

021 7515932; danang@equilab-int.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: April 25, 2024
• Primary Completion: May 25, 2024
• Study Completion: June 25, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

ID (1)