Next Generation Probiotics (NGPs) for Metabolic Health

Microbial Colonization Clinical Trial

Official title:

Next Generation Probiotics (NGPs) for Metabolic Health - Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229082
• Other study ID #: MFDU002
• Status: Completed
• Start date: April 8, 2016
• Est. completion date: June 9, 2017

Study information

• Verified date: January 2020
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 9, 2017
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Females.

2. Age between 20 to 50 years.

3. Obtained his/her informed consent after verbal and written information.

4. Sufficient general health and orientation for participating in the study as evaluated by the study personnel.

5. Have a high probability for compliance with and completion of the study.

6. Available for study visits and availability for food

7. Normal gastrointestinal function.

8. Willingness to provide faecal, urine and blood samples and keep food diary

Exclusion Criteria:

Lactobacillus Rhamnosus GG or reuteri, bifidobacteria enriched products) in the past 6 weeks. 12. Use of anti-obesity drugs. 13. Active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months. 14. Special diets e.g. Vegetarian, Vegan, Diets with intention to use certain limited food groups only (like paleo diet, egg-grape diet etc.) 15. History of chronic active inflammatory disorders. 16. History of bariatric surgery. 17. Regular use of non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs. 18. Ongoing or recent (last 3 months) antibiotic treatment. 19. Immunosuppression or ongoing therapy causing immunosuppression. 20. Use of vitamin supplementations beyond Recommended Daily Intake levels during the previous 2 months and during the study, except for vitamin D supplementation up to 20 µg/day.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

Intervention

Other:
• observational

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Danisco	4Pharma Ltd., Medfiles Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the differences in the intestinal microbiota profile between lean and obese subjects.		1 week