Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults

NCT01568567 | Completed Phase 1

• 2 other identifiers: CSP U-11-008CSUB0031
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults. Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.

Conditions

Safety

Keywords

safety; tolerance; lactobacillus Reuteri

Outcome Measures

Primary Outcomes (2)

• Safety measured by blood chemistry parameters

  To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.

  28 days

• Tolerability measured by blood chemistry parameters

  To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.

  28 days

Study Arms (3)

Double dose

ACTIVE COMPARATOR

One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide

Dietary Supplement: Lactobacillus Reuteri DSM 17938

Single dose

ACTIVE COMPARATOR

One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide

Dietary Supplement: Lactobacillus Reuteri DSM 17938

Placebo

PLACEBO COMPARATOR

One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide

Dietary Supplement: Lactobacillus Reuteri DSM 17938

Interventions

Lactobacillus Reuteri DSM 17938 DIETARY_SUPPLEMENT

One stick pack in the morning and one stick pack afternoon/evening for 28 days.

Double dose; Placebo; Single dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Age 18-65 years at visit 1
• BMI 19-29
• Hb ≥ 120 g/l for women and ≥ 130 g/l for men
• Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
• Signed informed consent and biobank consent

You may not qualify if:

• Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
• Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.
• Pregnant or lactating or wish to become pregnant during the period of the study.
• Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.

Sponsors & Collaborators

• Good Food Practice, Sweden: lead
• BioGaia AB: collaborator

Study Sites (1)

Good Food Practice Uppsala

Uppsala, 751 83, Sweden

Location

Study Officials

• Johan Olsson, PhD

  KPL Good Food Practice AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 2, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

SE (1)