CD: Prebiotics/Probiotics (2021)
Author and Year:
Pinto-Sanchez M, Smecuol E, et al, 2017
PubMed ID:
Article Title:
Bifidobacterium infantis NLS Super Strain Reduces the Expression of a-Defensin-5, a Marker of Innate Immunity, in the Mucosa of Active Celiac Disease Patients.
Authors:
Pinto-Sánchez M, Smecuol E, Temprano M, Sugai E, González A, Moreno M, Huang X, Bercik P, Cabanne A, Vázquez H, Niveloni S, Mazure R, Mauriño E, Verdú E, Bai J
Journal:
Journal of Clinical Gastroenterology
Year of publication:
2017
Volume:
51
Issue:
9
Page numbers:
814-817
Study Design:
Cross-Sectional Study
Risk of Bias Assessment Rating:
Negative
Inclusion Criteria:
Patients attending Dr. C. Bonorino Udaondo Gastroenterology Hospital; participant in one of the following: Group 1) Recently diagnosed celiac disease (CD) patients who were participants in a previous exploratory, randomized, double-blinded, placebo-controlled study and did not received gluten free diet [(GFD), Smecuol et al., J Clin Gastroenterol 2013;47;139-147] plus participants in a prior observational study (Nachman F, et al, Dig Liver Dis 2010;42:685-691); Group 2) CD patients treated with B. infantis NSL-SS on a gluten-containing diet for 3 weeks (Smecuol et al., J Clin Gastroenterol 2013;47;139-147); and Group 3) CD patients after 1 year of strict gluten free diet (GFD). CD diagnosis based on Marsh III or greater lesion on duodenal biopsies and concomitant positive anti-transglutaminase antibody and antideaminated gliadin peptides. Informed consent.
Exclusion Criteria:
Not reported
Research Purpose:
To investigate the potential mechanisms of a probiotic B. infantis Natren Life Start super strain on the mucosal expression of innate immune markers in adult patients with active untreated CD compared with those treated with B. infantis x 6 weeks and after 1 year of GFD.
Blinding efforts:
Immunohistochemistry and semiquantification was performed in a blinded manner by analyzing 3 fields with the highest positive-staining areas selected from each patient.
Study Location:
Buenos Aires, Argentina
Source(s) of Funding:
Government
Please specify names of funders:
Canadian Institutes of Health Research
|
Quality Criteria Checklist: Primary Research
|
|||
| Relevance Questions | |||
| 1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
| 2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
| 3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
| 4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
| Validity Questions | |||
| 1. | Was the research question clearly stated? | Yes | |
| 1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
| 1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
| 1.3. | Were the target population and setting specified? | Yes | |
| 2. | Was the selection of study subjects/patients free from bias? | ??? | |
| 2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | No | |
| 2.2. | Were criteria applied equally to all study groups? | Yes | |
| 2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
| 2.4. | Were the subjects/patients a representative sample of the relevant population? | ??? | |
| 3. | Were study groups comparable? | ??? | |
| 3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | Yes | |
| 3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | ??? | |
| 3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
| 4. | Was method of handling withdrawals described? | Yes | |
| 4.1. | Were follow-up methods described and the same for all groups? | Yes | |
| 4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | Yes | |
| 4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
| 5. | Was blinding used to prevent introduction of bias? | Yes | |
| 5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | Yes | |
| 5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | Yes | |
| 6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | ??? | |
| 6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | No | |
| 6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | ??? | |
| 6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | ??? | |
| 6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | No | |
| 6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | Yes | |
| 7. | Were outcomes clearly defined and the measurements valid and reliable? | ??? | |
| 7.1. | Were primary and secondary endpoints described and relevant to the question? | Yes | |
| 7.2. | Were nutrition measures appropriate to question and outcomes of concern? | ??? | |
| 7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | ??? | |
| 7.5. | Was the measurement of effect at an appropriate level of precision? | ??? | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | ??? | |
| 7.7. | Were the measurements conducted consistently across groups? | ??? | |
| 8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
| 8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
| 8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
| 8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
| 8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | Yes | |
| 8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | No | |
| 8.6. | Was clinical significance as well as statistical significance reported? | Yes | |
| 8.7. | If negative findings, was a power calculation reported to address type 2 error? | No | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | ??? | |
| 9.1. | Is there a discussion of findings? | Yes | |
| 9.2. | Are biases and study limitations identified and discussed? | No | |
| 10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
| 10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
| 10.2. | Was the study free from apparent conflict of interest? | Yes | |