Defining the Normal Human Response to Probiotics

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03140878
• Date of registration: 01/05/2017
• Prospective Registration: No
• Primary sponsor: Chr Hansen
• Public title: Defining the Normal Human Response to Probiotics
• Scientific title: Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions
• Date of first enrolment: April 16, 2017
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03140878
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Response to Probiotics

Intervention(s)

Dietary Supplement: LGG

Dietary Supplement: Placebo

Primary Outcome(s)

Genome-wide gene expression [Time Frame: 3 years]

Secondary Outcome(s)

16S analysis of luminal fluid [Time Frame: 3 years]

Secondary ID(s)

H-17002470

HND-GI-024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Copenhagen

Herlev Hospital