PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews Strains on the market: an investigation of the probiotic strains in the Canadian food supply and a review of their health effects Mary Scourboutakos, Beatriz Franco-Arellano, Elena Comelli, Mary L'Abbe, Sarah Murphy Citation Mary Scourboutakos, Beatriz Franco-Arellano, Elena Comelli, Mary L'Abbe, Sarah Murphy. Strains on the market: an investigation of the probiotic strains in the Canadian food supply and a review of their health effects. PROSPERO 2016:CRD Available from Review question(s) What health effects (as demonstrated by RCTs on humans) are associated with each of the probiotic strains/strain combinations found in the Canadian food supply? The probiotic strains/strains in the food supply are: - Bifidobacterium lactis BB-12 (found in: Yoplait Minigo [kid product] and Iogo) - Bifidobacterium lactis BB-12 + Lactobacillus acidophilus LA-5 (found in: Yoplait Yoptimal, Iogo, and Eating Right [Lucerne] Brand) - Lactobacillus acidophilus LA-5 (found in: Yog Active Fiber Cereal) - Lactobacillus casei DN (found in: Danone s DanActive) - Bifidobacterium lactis DN (found in: Danone s Activia) - Lactobacillus acidophilus NCFM (found in: President s Choice ProAdvantage) - Bifidobacterium lactis Bi-07 + Lactobacillus acidophilus NCFM (found in: BioBest) - Lactobacillus acidophilus Bi07 (found in: Irresistibles frozen fruit blend) - Bacillus coagulans GBI Searches Three databases will be searched by two independent researchers. Page: 1 / 6

2 1) PubMed 2) Web of Science 3) EMBASE Sample Keywords: Title or Abstract = ENTER STRAIN NAMES AND Title or Abstract = yogurt OR yoghurt OR milk OR fermented milk OR dairy OR ice cream AND All Fields = randomized controlled trial NOT All Fields = prebiotic OR prebiotics Types of study to be included Only randomized controlled trials will be included Condition or domain being studied Probiotics have been associated with a wide range of disease and clinical health endpoints ranging from increased regularity to enhanced immunity. This study will not evaluate a single health outcome, but rather will summarize the results of all RCTs that have tested the health effects of probiotic strains found in the food supply, when tested in a food format. Participants/ population Inclusion Criteria: Healthy populations Aged from toddlers to seniors Including pregnant populations Exclusion criteria: Infant populations Diseased populations (ex. diabetics) Intervention(s), exposure(s) RCTs that test the effects of the following strains in a dairy-based food format will be included: - Bifidobacterium lactis BB-12 - Bifidobacterium lactis BB-12 + Lactobacillus acidophilus LA-5 - Lactobacillus acidophilus LA-5 - Lactobacillus casei DN Page: 2 / 6

3 - Bifidobacterium lactis DN Lactobacillus acidophilus NCFM - Bifidobacterium lactis Bi-07 + Lactobacillus acidophilus NCFM - Lactobacillus acidophilus Bi07* - Bacillus coagulans GBI * * stared strains will be tested in any food or supplemental format, because these strain were not found in dairy products. All studies must administer the probiotic in a dosage of approximately 1 billion probiotics per food serving. Comparator(s)/ control The control/comparator will be a non-exposed equivalent group Context Notes about inclusion/exclusion criteria: TYPE OF STUDY: Randomized Controlled Trials on humans. They should be double blind. TREATMENT: The treatment must be a food containing the strain of interest QUANTIFIED DOSE: Must contain approximately 1 billion probiotics (if it contains a different amount please collect it and flag it) CONTROL: Must include a control group ROUTE OF EXPOSURE: Oral OUTCOME: we are looking for human clinical endpoints (ex. disease, or marker of disease, immune modulation counts etc.) POPULATION: healthy populations INCLUDING pregnant populations AGES: adults, children (2-18), seniors (note: infants and studies in infant formulas will be excluded) REPORT TYPE: Published in a peer-reviewed journal LANGUAGE: Must be in English PUBLICATION TIME: any time Additional inclusion/exclusion notes: - studies testing safety or tolerance will not be included - studies testing persistence and viability will not be included - RCTs testing synbiotics (combining a probiotic plus a prebiotic such as a fiber) will be excluded - RCTs testing products that contain additional strains (a symbiotic) will be excluded Outcome(s) Primary outcomes Page: 3 / 6

4 There is no specific health outcome being studied. Instead, we are looking to summarize what health effects result (either positive or negative) as a result of RCTs that test these strains in dairy products. Secondary outcomes None. Data extraction, (selection and coding) Data extraction will be performed by two independent researchers. The following data will be extracted: Reference: Strain Studied: Dose of Strain: Food Format: Is it double-blinded: Population: Sample Size: Study Duration: What health effect was studied: What health effects were observed: Funding Source: Risk of bias (quality) assessment A study quality assessment will be conducted using Health Canada s quality appraisal tool for intervention studies for assessing the validity of health claims on foods. Strategy for data synthesis The data will be aggregated into a study table to summarize the health effects associated with each strain. The table will have the following format: Brand Species & Strain(s) Health effects of the strain or strain combinations as seen in an RCT Evidence showing a benefit: Children: Adults: Seniors: Page: 4 / 6

5 Pregnant Women: Evidence showing no benefit: Children: Adults: Seniors: Pregnant Women: Analysis of subgroups or subsets None. Dissemination plans Upon completion the manuscript will be published in a peer-reviewed scientific journal. Contact details for further information Dr Scourboutakos 150 College St. maryscourboutakos@gmail.com Organisational affiliation of the review Department of Nutritional Sciences, Faculty of Medicine, University of Toronto Review team Dr Mary Scourboutakos, University of Toronto Mrs Beatriz Franco-Arellano, University of Toronto Professor Elena Comelli, University of Toronto Professor Mary L'Abbe, University of Toronto Miss Sarah Murphy, University of Toronto Collaborators Mary Scourboutakos, Anticipated or actual start date 01 May 2016 Anticipated completion date 18 August 2016 Funding sources/sponsors Lawson Family Chair in Microbiome Nutrition Research Earl W. McHenry Award Conflicts of interest None known Language English Page: 5 / 6

6 Powered by TCPDF ( Country Canada Subject index terms status Subject indexing assigned by CRD Subject index terms Canada; Food Microbiology; Food Supply; Humans; Lactobacillus; Probiotics; Sprains and Strains Any other information Please note: this is a two part-study that combines an original investigation of what strains are in the food supply along with a systematic review of the health effects associated with those strains Stage of review Ongoing Date of registration in PROSPERO 11 July 2016 Date of publication of this revision 11 July 2016 Stage of review at time of this submission Started Completed Preliminary searches Yes No Piloting of the study selection process Yes No Formal screening of search results against eligibility criteria No No Data extraction No No Risk of bias (quality) assessment No No Data analysis No No PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 6 / 6