|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ANZCTR |
|
Last refreshed on:
|
13 January 2020 |
|
Main ID: |
ACTRN12615001135505 |
|
Date of registration:
|
27/10/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The effects of probiotics on glycaemic control in Type 2 diabetes mellitus patients
|
|
Scientific title:
|
Gut Hormone and Anti-Inflammatory Pathways Underlying Probiotic-Effects on Glycaemic Control, Gut Microbiota and Quality of Life among Type 2 Diabetes Mellitus Patients: A Study Protocol |
|
Date of first enrolment:
|
01/12/2015 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://anzctr.org.au/ACTRN12615001135505.aspx |
|
Study type:
|
Interventional |
|
Study design:
|
Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Malaysia
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Neoh Chin Fen
|
|
Address:
|
Collaborative Drug Discovery Research group, Faculty of Pharmacy, Puncak Alam Campus, Universiti Teknologi MARA (UiTM), 42300 Puncak Alam Selangor
Malaysia |
|
Telephone:
|
+60332584708 |
|
Email:
|
neohchinfen@puncakalam.uitm.edu.my |
|
Affiliation:
|
|
|
|
Name:
|
Dr Neoh Chin Fen
|
|
Address:
|
Collaborative Drug Discovery Research group, Faculty of Pharmacy, Puncak Alam Campus, Universiti Teknologi MARA (UiTM), 42300 Puncak Alam Selangor
Malaysia |
|
Telephone:
|
+60332584708 |
|
Email:
|
neohchinfen@puncakalam.uitm.edu.my |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1) T2DM patients, with glycosylated hemoglobin (HbA1c) of 7% to 10%
2) No change in oral hypoglycaemic agents during the last 3 months
Exclusion criteria: 1.Already on insulin or insulin analogs or maximum dose of oral hypoglycaemic agents
2.Regular intake of probiotics (including fermented dairy products), antacids, H2-receptor blockers, proton pump inhibitors, loperamide, corticosteroids or sex steroids
3.Systemic antibiotics within 1 month before inclusion
4.Active smokers (still smoking at least 1 cigarette for the past 6 months)
5.Daily alcohol consumption >30 g
6.Significant immunodeficiency
7.Liver, thyroid, kidney or cardiac valvular disorder
8.Chronic gastrointestinal disease
9.Neurological disorders (e.g. Alzheimer's disease, stroke, Parkinson disease)
10.Breast-feeding, pregnancy or plan to become pregnant in the next 6-12 months
11.Participation in another clinical trial within the last 6 months
12.Enduring mental health problems (e.g. schizophrenia, bipolar disorder)
13.Incapacity to give consent
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both males and females
|
|
Health Condition(s) or Problem(s) studied
|
|
Metabolic and Endocrine - Diabetes
|
|
Alternative and Complementary Medicine - Other alternative and complementary medicine
|
Type 2 Diabetes Mellitus;
Type 2 Diabetes Mellitus
|
|
Intervention(s)
|
Patients will be assigned randomly to receive a capsule of 10 billion CFU probiotic mixture twice daily (Probio-Tec Registered Trademark, Chr Hansen Holding A/S, Denmark) or placebo, for a duration of 24 weeks.
a) Composition of probiotic mixture: Bifidobacterium BB-12 Registered Trademark and
Lactobacillus rhamnosus LGG Registered Trademark (LGG Registered Trademark is a registered trademark of Valio Ltd.) (50%:50%)
b) dose of each microorganism: 1 billion CFU for each strain per capsule
c) mode of administration: oral capsule
Adherence assessment: Pill(capsule) counting, clinic appointment, phone interview and self-reported assessment
|
|
Primary Outcome(s)
|
glycosylated hemoglobin (HbA1c)
Assess by: ELISA kit
[At baseline, Week 12 and Week 24 follow up]
|
|
Secondary Outcome(s)
|
|
Gut hormone: glucagon-like peptide 1 (GLP-1). Assess by: ELISA kits/serum assay[At baseline, Week 12 and Week 24 follow up]
|
Lipid profile (total cholesterol, HDL, LDL, TG)
Assess by: Serum assay (Will be done by hospital laboratory)[At baseline, week12, and week 24 follow up]
|
|
Gut Microbiota Profiling (Metagenomic Sequencing) Assess by: QIAamp DNA Stool Mini Kit and Genomic Sequencing[At baseline, Week 12 and Week 24 follow up]
|
|
Glycaemic parameters [fasting blood glucose (FBG), insulin)] Assess by: ELISA kits/ serum assay[At baseline, Week 12 and Week 24 follow up]
|
|
Diabetes quality of life score Assess by: Validated Malaysian version of Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI)[At baseline, week 12 and week 24 follow up]
|
|
Stress oxidative parameters [blood superoxide dismutase (SOD) activity, glutathione peroxidase (GPx) activity, catalase (CAT) activity, gluthathione (GSH), gluthatione reductase (GR), malondialdehyde (MDA)] Assess by: ELISA kits/serum assay[At baseline, week 12 and week 24 follow up]
|
Inflammatory markers [C-reactive protein, TNF-a, IL-6, IL-10]
Assess by: ELISA kit/serum assay[At baseline, week12, and week 24 follow up]
|
Anthropometric measurements (weight, height, BMI, waist circumference, hip circumference)
Assess by: Standard method of measuring (measurement tape and etc.)[At baseline, week 12 and week 24 follow up]
|
|
Source(s) of Monetary Support
|
|
Ministry of Education
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Universiti Teknologi MARA Research Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|