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Study Title and Description

A randomized double-blind placebo-controlled trial of a multi-strain probiotic in treatment of symptomatic uncomplicated diverticular disease.-B



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title A randomized double-blind placebo-controlled trial of a multi-strain probiotic in treatment of symptomatic uncomplicated diverticular disease.-B
Author Kvasnovsky CL., Bjarnason I., Donaldson AN., Sherwood RA., Papagrigoriadis S.
Country University of Maryland Medical Center, Baltimore, MD, USA.
Year 2017
Numbers Pubmed ID: 28528364

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number Title Description Comments
1 Pharm: Probiotics Symprove
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2 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4a: Pharmacologic (recur prev)
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KQ 4a: Pharmacologic (recur prev)
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Study Design RCT
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RCT
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RCT
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Country USA
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Canada
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Germany
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Other ... Finland, Hungary, Italy, Netherlands, Romania, South Africa (from NCT)
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Funder Industry (fully or in part)
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Study name
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Associated articles
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ClinicalTrials.gov identifier NCT02115867
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Start and end years of the Study 2007
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2011
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Inclusion criteria Persistent abdominal symptoms (of >= 3-month duration) w/ a diagnosis of uncomplicated diverticulosis (diagnosis of diverticulosis established by colonoscopy and/or CT scan, with or without raised inflammatory markers, and without a past diagnosis of IBS).
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Exclusion criteria Surgery for diverticulitis or its attendant complications, right-sided diverticulitis, and predominant bleeding symptoms.
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... Colonoscopy and/or CT
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If NRCS, what analytic method was used to account for differences between study arms?
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How was diverticulitis diagnosed Colonoscopy and/or CT scan, w/ or w/o raised inflammatory markers, and without a past diagnosis of IBS
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Pharm: Probiotics Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 55.6 Male 44.4
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White 51.7 White 48.3
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Black 50 Black 50
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Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 33.3 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 66.7
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Participant Age - Continuous data (in years) Median 60 Median 63.5
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IQR 52-72 IQR 54-72.5
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) No data entered.
History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Hazard Ratio (HR) 95% CI low 95% CI high
Outcome: Acute Colonic Diverticulitis free time      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: Probiotics Placebo Comparison Measure Pharm: Probiotics vs. Placebo


Enter a numeric value or title (required) years

N Analyzed NR NR 0.12
Percentage 4 32 0.01
0.97


Quality Dimensions
Dimension Value Notes Comments
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence No Randomization performed with a computerized protocol.
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment No The placebo and probiotic were packaged in identical sealed boxes, identified by a trial batch/code number only.
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study No Double-blind
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. No Double-blind
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. No Outcome assessors were blinded (from NCT).
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No Reasons for missing data were <20% for short-term follow-up and reasons for missing outcome data were explained.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Yes Poorly reported, post hoc, subgroup analysis that is likely highly at risk for reporting bias.
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No Study appears to be free of other sources of bias.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Yes Outcome assessors were blinded (from NCT).
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.