Lacticaseibacillus Rhamnosus GG Pili Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

NCT01551186

Infectious Disease of Digestive Tract

COMPLETED PHASE4

Probiotics to Promote Intestinal Health

NCT02046512

Communicable Diseases Infection Anti-Infective Agents +2 more

COMPLETED PHASE4

The Effect of a Probiotic on Upper Respiratory Tract Infections

NCT03636191

Infections, Upper Respiratory Tract

COMPLETED NA

Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women

NCT06821789

Patients With Bacterial Vaginosis

NOT_YET_RECRUITING NA

Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19

NCT04399252

Microbiome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The individuals did receive the three treatment combinations in a randomised order.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wild-type

Supplementation with the wild-type of the LGG strain

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Low-pill

Supplementation with the low-pili LGG strain

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

High-pili

Supplementation with the high-pili LGG strain

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LGG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes