Defining the Normal Human Response to Probiotics

NCT03140878 | Completed

• 2 other identifiers: HND-GI-024H-17002470
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Response to Probiotics

Outcome Measures

Primary Outcomes (1)

• Genome-wide gene expression

  The effect of LGG on genome-wide gene expression in intestinal tissue and cells

  3 years

Secondary Outcomes (1)

• 16S analysis of luminal fluid

  3 years

Study Arms (2)

LGG

EXPERIMENTAL

Lactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water

Dietary Supplement: LGG

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

LGG DIETARY_SUPPLEMENT

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

LGG

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men or women
• No medication
• Age between 18 and 35 years
• BMI below 30
• Provided voluntary written informed consent

You may not qualify if:

• All clinical diagnoses and disorders requiring medicine
• Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome.
• Pregnant and women who are breast-feeding
• Patient with known blood clothing disorders
• Patients with clinical psychiatric diagnoses (including dementia)
• Individuals who have undergone abdominal surgery, which might have effect on the GI function, except appendectomy and cholecystectomy
• Individuals with high blood pressure (≥140 mmHg /90 mmHg)
• Systemic use of antibiotics or steroids or antimicrobial medication in the last 4 months
• Daily usage of NSAID in the last 2 months or incidental use in the last 2 weeks prior to screening
• Usage of medications, except oral contraceptives, during the 14 days prior to screening
• Lactose intolerance
• Participation in other clinical trials in the past three months
• Regular use of probiotics in the last 6 weeks
• Smoking
• Planned changes to current diet or exercise regime

Sponsors & Collaborators

• Chr Hansen: lead
• University of Copenhagen: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Herlev hospital

Copenhagen, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33274667 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 4, 2017
• Study Start: April 16, 2017
• Primary Completion: June 11, 2017
• Study Completion: June 11, 2017
• Last Updated: April 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)