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. 2021 Nov 29;2021(11):CD013531. doi: 10.1002/14651858.CD013531.pub2

Tapete 2018.

Study characteristics
Methods RCT
Setting: NS, Italy
Study period: 2017
The study presents results for the IBD cohort as a whole, does not separate between CD and UC. Where separate data do exist they are presented below.
Participants Inclusion criteria: clinical remission (CDAI < 150 for CD and full Mayo < 3 for UC) with normal values of ESR, CRP, white blood cells and neutrophil count, but with residual intestinal symptoms (abdominal pain, bloating, and abnormal stool consistency ‐ Bristol stool classification > 5)
Exclusion criteria: NS
Age (mean ± SD): NS
Sex (M/F): NS
Site of disease: NS
Use of concurrent medication: NS
Disease activity: inactive
Disease duration: NS
Number randomised: IG: 10; CG: 20
Number reaching end of study: NS
Number analysed: NS
Postrandomisation exclusion: NS
Interventions IG: low FODMAP diet
CG: sham control diet
Outcomes Length of intervention: 6 to 8 weeks
Primary outcomes:
Abdominal pain intensity measured on a 0‐to‐10‐centimetre VAS.
Secondary outcomes:
None reported
Notes Funding source: NS
Conflict of interest: NS
Author contact details: g.tapete@studenti.unipi.it
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk NS. We contacted the author but received no response.
Allocation concealment (selection bias) Unclear risk NS. We contacted the author but received no response.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk NS. We contacted the author but received no response.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk More information is needed. We contacted the author but received no response.
Selective reporting (reporting bias) Low risk The outcomes mentioned in the methods are reported in the results.
Other bias Low risk No apparent sources of bias; conflicts of interest are not clear, but not downgraded