Defining the Normal Human Response to Probiotics

Chr. Hansen

Status: Completed

Conditions: Healthy Response to Probiotics

Treatments: Dietary Supplement: Placebo; Dietary Supplement: LGG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03140878

HND-GI-024

H-17002470 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

29 participants in 2 patient groups, including a placebo group

LGG

Experimental group

Description:

Lactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water

Treatment:

Dietary Supplement: LGG

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo