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OpenTrials
Completed

NCT Number: NCT01568567

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

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.

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Key information

Conditions

Safety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Good Food Practice Uppsala

Uppsala, 751 83, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Lactobacillus reuteri DSM 17938

Dietary Supplement

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

Primary outcomes

  1. Safety measured by blood chemistry parameters

    Time frame: 28 days

    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.

  2. Tolerability measured by blood chemistry parameters

    Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Good Food Practice, Sweden

Industry

Collaborators

  • BioGaia AB

Registry information

Official study title

To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study

Acronym: BSSII

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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