Lactobacillus Plantarum DR7 for Gut-Brain-Axis Benefits

NCT03370458 | Completed DMC

• 1 other identifier: USM/JEPeM/17040228
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health properties, primarily alleviation of stress, among adults in Malaysia aged from 18 to 60 years.

Conditions

Stress

Outcome Measures

Primary Outcomes (3)

• Alleviation of stress

  To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in alleviation of stress using PSS questionnaire

  12 weeks

• Alleviation of depression

  To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in alleviation of depression using DASS42 questionnaire

  12 weeks

• Enhancement of cognition ability

  To evaluate the potential of oral administration of Lactobacillus plantarum DR7 in enhancing cognition ability using Cogstate Brief Battery

  12 weeks

Secondary Outcomes (3)

• Alleviation of respiratory tract infections

  12 weeks

• Alleviation of gastrointestinal disorders

  12 weeks

• Enhancement of immunity

  12 weeks

Study Arms (2)

Lactobacillus plantarum DR7

EXPERIMENTAL

Intervention consists of daily administration of 2g probiotic Lactobacillus plantarum DR7, administered daily at a fixed dosage of 9 log CFU/sachet/day and continue for 12 weeks. Intervention: Dietary Supplement: Lactobacillus plantarum DR7

Dietary Supplement: Lactobacillus plantarum DR7

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 weeks. Intervention: Dietary Supplement: Placebo

Dietary Supplement: Placebo

Interventions

Lactobacillus plantarum DR7 DIETARY_SUPPLEMENT

This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years. Secondary emphases include respiratory and gastrointestinal health

Also known as: DR7

Lactobacillus plantarum DR7

Placebo DIETARY_SUPPLEMENT

This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years. Secondary emphases include respiratory and gastrointestinal health

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects
• years old
• Willing to commit throughout the experiment
• Have moderate stress and beyond, as per determined by PSS test

You may not qualify if:

• Type-1 diabetes (one of the main metabolite of Lactobacillus is acetic acid. Acetic acid has been reported to affect lipid metabolism in the liver and fat digestion in the pancreas in animal studies, and has been applied in obesity studies)
• Long term medication due to certain severe illness (certain medications may interfere with the survivability of Lactobacillus in the gut, for example the interactions between probiotics and warfarin
• HIV/AIDS (there has been no substantial data on the detrimental effects of probiotics on AIDS patients. However, AIDS patient may be immune-compromised in the sense of "leaky gut" that may lead to bacterial translocation, including translocation of Lactobacillus outside the gut environment, into the blood stream)
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (there has been no substantial data on the detrimental effects of probiotics on G6PD deficiency people. However, certain strains of probiotics have been reported to benefit RBC irregularity disorders such as spur cells formation. One of the main mechanisms, involve the alteration of RBC membrane. Although this is a benefit, we are unsure of the effects on G6PD deficiency people, with weaker RBC).

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Clinical Nutrition Sdn Bhd: collaborator

Study Sites (1)

School of Industrial Technology, Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

Location

Study Officials

• MT Liong, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking will be subjected to Participant, Care Provider, Investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: Placebo and DR7 will be administered via a parallel design

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: December 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)