The effect of probiotics used as a single therapy on functional constipation: Study protocol for a systematic review and meta-analysis

BACKGROUND: Constipation is a frequent gastrointestinal symptom. It is intimately related to many diseases. 1st-line therapy can not alleviate constipation for some patients. Alternative treatments are therefore commonly used, such as probiotics. Nevertheless, the efficacy and safety of probiotics used as a single treatment are still uncertain. A systematic review and meta-analysis will be carried out to answer the issue. METHODS: The protocol accompanied Preferred Reporting Items for Systematic Reviews and Protocol Meta-Analysis. PubMed, Cochrane, Embase, and Web of Science databases were practiced for randomized controlled trials without language constraint. In addition, We have also conducted backward (manually) and forward (with Google Scholar) citation checks to identify any additional relevant papers. Two reviewers will conduct studies selection, data extraction, and risk of bias assessment independently. The primary outcome is treatment success (spontaneous bowel movements (sBMs) >3 times per week), defecation frequency. The second result will be consistency, fecal incontinence, other symptoms (e.g. flatulence, abdominal pain), and adverse event rates and types. RESULTS: This study provides helpful information about whether probiotics can be used as a single therapy on functional constipation CONCLUSION: The findings of the review will be disseminated through peer-review publications