Lacticaseibacillus Rhamnosus GG Pili Study

• Sponsor: Örebro University, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT05461443
• Collaborator: Valio Ltd (Industry), Chr Hansen (Industry)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 15
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Probiotic	N/A

Detailed Description

The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals received the three treatment combinations in a randomised order. Each supplementation was given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the duodenum were collected at the end of 6 h-solutions administration by flexible gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation. Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days days after administrations of each oral supplementation. The supplementations were separated by a 3-week wash-out period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The individuals did receive the three treatment combinations in a randomised order.The individuals did receive the three treatment combinations in a randomised order.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: The sachets containing the different LGG strains were labelled as A, B, and C. The codes for each strain were kept by the industrial partner that provided the probiotic strains. Only at the end of the data analyses were the codes disclosed
• Primary Purpose: Basic Science
• Official Title: Study of the Modularity Immune Function of Lactobacillus Rhamnosus GG in the Small Intestine of Healthy Individuals
• Actual Study Start Date: Mar 31, 2016
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Wild-type Supplementation with the wild-type of the LGG strain	Dietary Supplement: Probiotic; Other Names: LGG
Experimental: Low-pill Supplementation with the low-pili LGG strain	Dietary Supplement: Probiotic; Other Names: LGG
Experimental: High-pili Supplementation with the high-pili LGG strain	Dietary Supplement: Probiotic; Other Names: LGG

Outcome Measures

Primary Outcome Measures

1. Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain [6hrs supplementation after start of LGG strain administration.]

   Microarray-based Gene expression Analysis were carried out from duodenal biopsies collected after the supplementation of each LGG strain

2. Microbiome of duodenal mucosal biopsies [6hrs supplementation after start of LGG strain administration]

   Bacterial composition was analysed by Illumina MiSeq sequencing the hypervariable V3-V4 region of the 16S rRNA gene

Secondary Outcome Measures

1. Faecal microbiome [2 days after LGG strain administration]

   Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

2. Faecal microbiome [7 days after LGG strain administration]

   Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

3. Faecal microbiome [14 days after LGG strain administration]

   Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy males or females aged 18-65 years.

• Willing to abstain from any probiotics or medication known to alter gastrointestinal function during the study.

• A signed informed consent.

Exclusion Criteria:

• Recent or current treatment with drugs affecting intestinal function, immune function or mood (e.g. antidepressants). In addition use of all drugs during the study should be recorded.

• Recent (< 6 weeks) use of probiotics*.

• Diagnosis of major psychiatric or somatic disorders.

• Pregnancy or breastfeeding.

• Abuse of alcohol or drugs.

• Smokers and chewable tobacco users.

• Lactose intolerance.

• Any kind of probiotics and with special attention on products containing LGG:

Dairy products:

• Valio Kefir

• Valio Gefilus yoghurt

Dietary supplements:

• Bifiform Daily

• Bifiform Travel

• Bifiform Daily Caps

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Örebro University	Örebro		Sweden	703 62

Sponsors and Collaborators

• Örebro University, Sweden
• Valio Ltd
• Chr Hansen

Investigators

• Study Director: Robert Brummer, Professor, Örebro University, School of Medical Sciences, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Brummer, Professor, Örebro University, Sweden
• ClinicalTrials.gov Identifier: NCT05461443
• Other Study ID Numbers: 2015/422
• First Posted: Jul 18, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Robert Brummer, Professor, Örebro University, Sweden: Lacticaseibacillus rhamnosus GG; Probiotics; Pili; Gut microbiota; Transcriptomics; Small intestine

Study Results

No Results Posted as of Jul 18, 2022