Defining the Normal Human Response to Probiotics

Healthy Response to Probiotics Clinical Trial

Official title:

Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140878
• Other study ID #: HND-GI-024
• Secondary ID: H-17002470
• Status: Completed
• Phase: N/A
• First received: May 1, 2017
• Last updated: April 20, 2018
• Start date: April 16, 2017
• Est. completion date: June 11, 2017

Study information

• Verified date: April 2018
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells

Description:

The study includes 3 visits. The first visit serves to check inclusion/exclusion criteria/complete questionnaire/give information about the study and receive consent. At visit 2 and 3 the included individuals will drink a placebo blend or a drink containing Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper intestine during endoscopy while under nurse administered propofol sedation (NAPS). There will be four weeks between visit 2 and 3.

At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will be collected, and one blood sample will be collected.

The down stream analysis will include a combination of gene expression analysis, microbiome analysis and classification of the individuals based on analysis of blood samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 11, 2017
• Est. primary completion date: June 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Healthy men or women

2. No medication

3. Age between 18 and 35 years

4. BMI below 30

5. Provided voluntary written informed consent

Exclusion Criteria:

1. All clinical diagnoses and disorders requiring medicine

2. Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome.

3. Pregnant and women who are breast-feeding

4. Patient with known blood clothing disorders

5. Patients with clinical psychiatric diagnoses (including dementia)

6. Individuals who have undergone abdominal surgery, which might have effect on the GI function, except appendectomy and cholecystectomy

7. Individuals with high blood pressure (=140 mmHg /90 mmHg)

8. Systemic use of antibiotics or steroids or antimicrobial medication in the last 4 months

9. Daily usage of NSAID in the last 2 months or incidental use in the last 2 weeks prior to screening

10. Usage of medications, except oral contraceptives, during the 14 days prior to screening

11. Lactose intolerance

12. Participation in other clinical trials in the past three months

13. Regular use of probiotics in the last 6 weeks

14. Smoking

15. Planned changes to current diet or exercise regime

16. Use of laxatives, anti-diarrheals, anti-cholinergics within last 4 weeks prior to screening

17. Use of immunosuppressant drugs within last 4 weeks prior to screening

18. Ulcer or malignancy in the intestine which is discovered during second visit

Related Conditions & MeSH terms

• Healthy Response to Probiotics

Intervention

Dietary Supplement:
• LGG
LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)
• Placebo
Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Locations

Country	Name	City	State
Denmark	Herlev hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Chr Hansen	Herlev Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genome-wide gene expression	The effect of LGG on genome-wide gene expression in intestinal tissue and cells	3 years
Secondary	16S analysis of luminal fluid		3 years