Lacticaseibacillus Rhamnosus GG Pili Study

Örebro University, Sweden

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05461443

2015/422

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 3 patient groups

Wild-type

Active Comparator group

Description:

Supplementation with the wild-type of the LGG strain

Treatment:

Dietary Supplement: Probiotic

Low-pill

Experimental group

Description:

Supplementation with the low-pili LGG strain

Treatment:

Dietary Supplement: Probiotic

High-pili

Experimental group

Description:

Supplementation with the high-pili LGG strain

Treatment:

Dietary Supplement: Probiotic