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. |
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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 |
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Interventions |
IG: low FODMAP diet CG: sham control diet |
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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 |
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Notes | Funding source: NS Conflict of interest: NS Author contact details: g.tapete@studenti.unipi.it |
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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 |