What is the purpose of the study?

The purpose of this study is to evaluate whether the probiotic Humiome® B. lactis – DSM 34602 can improve gut microbiota composition, reduce inflammation, and help regulate weight in overweight or obese adults.

Why is this study important?

This study is important because over half of Malaysians are overweight or obese, increasing their risk of chronic diseases. Gut dysbiosis and intestinal inflammation play key roles in obesity. Understanding whether B. lactis can support gut health, reduce inflammation, and help manage weight could lead to better, microbiome-targeted strategies for weight control.

What type of study is this?

This is a randomised, single-blind, controlled intervention trial. Participants are randomly assigned to receive either the probiotic or a placebo daily for 8 weeks, with their gut microbiome, inflammation markers, and weight-related outcomes monitored throughout the study.

How long will I be involved in this study?

Participants will be involved in the study for approximately 8 weeks, during which they will take a daily supplement, attend briefings, and provide stool, urine, and health measurements at the start (week 0), midpoint (week 4), and end (week 8) of the study.

What will happen to any samples I give?

The samples you provide will be used only for this study. They will be securely stored and may be analyzed for related research in the future in compliance with ethical and regulatory guidelines. Specimens will be processed at Monash University Malaysia. Unprocessed samples will be securely stored at -80°C at the earliest opportunity. All specimens and data will be handled in compliance with ethical and regulatory guidelines, ensuring the utmost confidentiality and security.

At the end of the study, any remaining samples may be retained for future research for seven (7) years, subject to your consent. Specimens no longer required will be destroyed following institutional policies to ensure proper disposal.

Will my medical information be kept private?

All information obtained in the study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. This study has been approved by the Monash University Human Research Ethics Committee (MUHREC) [Project ID: 46757]. Only researchers involved in this study will access your data while your study data will be securely stored in password protected spreadsheets. Deidentified data may be shared on the ROBOT platform and DNA sequencing data deposited in GenBank for research purposes. When publishing or presenting the study results, your identity will not be revealed without your expressed consent. 

Will I be informed of the study findings?

The overall study results will not be informed to you. However, it may be available in the form of journal publication.

Who should I contact if I have questions?

If you have any questions about the study, you may contact Associate Professor Dr Chong Chun Wie (ChongChunWie@monash.edu) for further information.