Defining the Normal Human Response to Probiotics

NCT ID: NCT03140878

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-16
• Study Completion Date: 2017-06-11

Brief 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

Detailed 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.

Conditions

Healthy Response to Probiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LGG

Lactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water

Group Type: EXPERIMENTAL

LGG

Intervention Type: DIETARY_SUPPLEMENT

LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Placebo

The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Interventions

LGG

LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Herlev Hospital

OTHER

Sponsor Role: collaborator

Chr Hansen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Herlev hospital

Copenhagen, , Denmark

Countries

Denmark

References

Bornholdt J, Broholm C, Chen Y, Rago A, Sloth S, Hendel J, Melsaether C, Muller CV, Juul Nielsen M, Strickertsson J, Engelholm L, Vitting-Seerup K, Jensen KB, Baker A, Sandelin A. Personalized B cell response to the Lactobacillus rhamnosus GG probiotic in healthy human subjects: a randomized trial. Gut Microbes. 2020 Nov 9;12(1):1-14. doi: 10.1080/19490976.2020.1854639.

Reference Type: DERIVED

PMID: 33274667 (View on PubMed)

Other Identifiers

H-17002470

Identifier Type: REGISTRY

Identifier Source: secondary_id

HND-GI-024

Identifier Type: -

Identifier Source: org_study_id