Tolerability and Risk of Adverse Events With a Probiotic Supplement

NCT03728868 | Completed DMC

• 1 other identifier: META002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced presence of it has been associated with an imbalance in the gastrointestinal flora of metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8 consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a positive way.

Conditions

Healthy Individuals

Keywords

Faecalibacterium prausnitzii; Desulfovibrio piger; tolerability; blood glucose levels

Outcome Measures

Primary Outcomes (1)

• Tolerability of the oral intake of F. prausnitzii and D. piger, defined as study discontinuation due to adverse events under 8 weeks of treatment.

  How well treatment with the study product compared to placebo is tolerated, which is primarily defined as termination due to adverse events under 8 weeks of treatment.

  0-8 weeks

Secondary Outcomes (15)

• Gastrointestinal side effects, measured using the Gastrointestinal Symptom Rating Scale (GSRS)

  0-8 weeks

• Effects on inflammation - erythrocyte sedimentation rate (safety parameters )

  0-8 weeks

• Effects on inflammation - CRP (safety parameters )

  0-8 weeks

• Effect on hematopoiesis - red blood cells (safety parameters)

  0-8 weeks

• Effect on hematopoiesis - white blood cells (safety parameters)

  0-8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

One capsule containing placebo (identical to the capsule with active product (F. prausnitzii and D. piger) in taste and appearance but without the active component) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks.

Dietary Supplement: Placebo

High dose F. prausnitzii and D. piger

ACTIVE COMPARATOR

One capsule (containing F. prausnitzii and D. piger at a dose of 1E9-5x1E9 colony forming units per bacterial strain) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks.

Dietary Supplement: High dose F. prausnitzii and D. piger

Low dose F. prausnitzii and D. piger

ACTIVE COMPARATOR

One capsule (containing F. prausnitzii and D. piger at a dose of 1E8-5x1E8 colony forming units per bacterial strain) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks.

Dietary Supplement: Low dose F. prausnitzii and D. piger

Interventions

Placebo DIETARY_SUPPLEMENT

Dietary supplementation with placebo once a day for 8 consecutive weeks

Placebo

High dose F. prausnitzii and D. piger DIETARY_SUPPLEMENT

Dietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks

High dose F. prausnitzii and D. piger

Low dose F. prausnitzii and D. piger DIETARY_SUPPLEMENT

Dietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks

Low dose F. prausnitzii and D. piger

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 40 years old
• Signed consent for participation
• Healthy individuals without any known diseases
• Willingness and ability to attend to planned visits, participate in telephone interviews and follow study instructions
• Understanding the Swedish language in spoken and written terms

You may not qualify if:

• Ongoing treatment with prescription drugs
• Regular or sporadic intake of probiotic products (foods with probiotics are allowed)
• Treated with antibiotics during the last 3 months
• Pregnancy
• Have experienced gastrointestinal tract symptoms (during the last month), which could affect study participation, as deemed by study physician.
• Current tobacco use (smoking or snuff)
• Participation in another clinical study

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• MetaboGen AB: collaborator

Study Sites (1)

Geriatric Medicine, Sahlgrenska University Hospital, Mölndal

Gothenburg, Västra Götaland County, 43180, Sweden

Location

Related Publications (12)

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• Sokol H, Pigneur B, Watterlot L, Lakhdari O, Bermudez-Humaran LG, Gratadoux JJ, Blugeon S, Bridonneau C, Furet JP, Corthier G, Grangette C, Vasquez N, Pochart P, Trugnan G, Thomas G, Blottiere HM, Dore J, Marteau P, Seksik P, Langella P. Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients. Proc Natl Acad Sci U S A. 2008 Oct 28;105(43):16731-6. doi: 10.1073/pnas.0804812105. Epub 2008 Oct 20.

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  PMID: 37532933 DERIVED

Study Officials

• Mattias Lorenzon, MD, PhD

  Dept Geriatrics, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief physician

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: November 2, 2018
• Study Start: October 10, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)