Defining the Normal Human Response to Probiotics | NCT03140878

Studies
Defining the Normal Human Response to Probiotics

NCT03140878

Sponsor

Chr Hansen

Status

Completed

Last Update Posted

Apr 23, 2018Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Healthy Response to Probiotics

Interventions

LGG
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-17002470	Registry Identifier	Regional ethical committee Denmark

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2017Actual

Primary Completion Date

Jun 11, 2017Actual

Completion Date

Jun 11, 2017Actual

First Submitted Date

May 1, 2017

First Submission Date that Met QC Criteria

May 3, 2017

First Posted Date

May 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2018

Last Update Posted Date

Apr 23, 2018Actual

Name	Class
University of Copenhagen	OTHER
Herlev Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LGG	Dietary Supplement	LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)	LGG

Measure	Description	Time Frame
Genome-wide gene expression	The effect of LGG on genome-wide gene expression in intestinal tissue and cells	3 years

Measure	Description	Time Frame
16S analysis of luminal fluid		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Use of laxatives, anti-diarrheals, anti-cholinergics within last 4 weeks prior to screening
Use of immunosuppressant drugs within last 4 weeks prior to screening
Ulcer or malignancy in the intestine which is discovered during second visit

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33274667	Derived	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.