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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665961
Other study ID # MiPOOP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2016
Est. completion date September 26, 2017

Study information

Verified date September 2018
Source Changi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome. Healthy subjects (n=35) provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of inflammatory cytokines. Their associations with central obesity were examined.


Description:

Introduction: Perturbance in the composition of human gut microbiota has been associated with metabolic disorders such as obesity, diabetes mellitus and insulin resistance. The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome.

Methods: Subjects of Chinese (n=14), Malay (n=10) or Indian (n=11) ancestry, median age 39 (range:22-70 years old), were enrolled. The subjects provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of biomarkers (Interleukin-6, tumour necrosis factor alpha, adiponectin, cleaved cytokeratin 18, lipopolysaccharide binding protein and limulus amebocyte lysate). Central obesity was defined by waist circumference cut-offs in Asians.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 26, 2017
Est. primary completion date September 26, 2017
Accepts healthy volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria:

- Provision of signed written informed consent,

- Aged between 21- 75 years old,

- Body Mass Index (BMI) of > 18 kg/m2,

- Ethnic group of either Chinese, Malay or Indian as evidenced by identification card,

- Subject with absence of impaired glucose tolerance,

- Subject is healthy with no clinically significant disease or condition as determined through their medical history, physical examination; Diabetes mellitus was defined as Type 2 DM fulfilling the WHO criteria and the care of Department of Endocrinology, Changi General Hospital,

- Ability to communicate with investigator and to understand and comply with all requirements of study participation.

Exclusion Criteria:

- Subject who are viral Hepatitis (B or C) or HIV positive as per declaration,

- Subject who had bariatric surgery including lap banding, gastric sleeve surgery, cholecystectomy,

- Subject who has > 5% weight loss in the last 3 months prior to study enrolment as per declaration,

- Subject who are on 'stable' insulin sensitizers such as such as rosiglitazone, metformin for the last 3 months prior to enrolment,

- Pregnant women,

- Subject who has been treated with antibiotics within 6 weeks of enrolment,

- Subject who has usage of lactulose, dietary fibres for purpose of constipation,

- Subject with immune-compromised status; undergoing chemotherapy, on steroid,

- Subject with FMHx or PMHx of autoimmune disease, GI cancers, inflammatory bowel disease, Irritable bowel syndrome and anxiety or depression as per declaration.

Study Design


Locations

Country Name City State
Singapore Changi General Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
Changi General Hospital Genome Institute of Singapore, A*Star

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Ho EXP, Cheung CMG, Sim S, Chu CW, Wilm A, Lin CB, Mathur R, Wong D, Chan CM, Bhagarva M, Laude A, Lim TH, Wong TY, Cheng CY, Davila S, Hibberd M. Human pharyngeal microbiota in age-related macular degeneration. PLoS One. 2018 Aug 8;13(8):e0201768. doi: 10.1371/journal.pone.0201768. eCollection 2018. — View Citation

Hsiang JC, Bai WW, Raos Z, Stableforth W, Upton A, Selvaratnam S, Gane EJ, Gerred SJ. Epidemiology, disease burden and outcomes of cirrhosis in a large secondary care hospital in South Auckland, New Zealand. Intern Med J. 2015 Feb;45(2):160-9. doi: 10.1111/imj.12624. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Association of human gut microbiome profile with central obesity and dietary pattern Species diversity as measured by diversity indices 1 day
Secondary Association of human gut microbiome profile with ethnicity Species diversity as measured by diversity indices 1 day
Secondary Association of interleukin-6 with central obesity and microbiota Interleukin-6 concentration in pg/ml 1 day
Secondary Association of tumour necrosis factor - alpha with central obesity and microbiota Tumour necrosis factor - alpha concentration in pg/ml 1 day
Secondary Association of cleaved cytokeratin 18 with central obesity and microbiota Cleaved cytokeratin 18 concentration in units/L 1 day
Secondary Association of limulus amebocyte lysate with central obesity and microbiota Limulus amebocyte lysate concentration in EU/ml 1 day
Secondary Association of lipopolysaccharide binding protein with central obesity and microbiota Lipopolysaccharide binding protein concentration in ng/ml 1 day
Secondary Analysis of dietary components based on recommended daily allowance Dietary questionnaire 3 days
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