Tapete 2019.
Study characteristics | ||
Methods | RCT, cross‐over Setting: NS, Italy Study period: NR 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: UC or CD with normal inflammatory parameters (CRP, white blood cells) and no clinical activity (CDAI < 150 for CD and a full Mayo < 2 for UC) but with residual abdominal symptoms (abdominal pain, diarrhoea, bloating) Exclusion criteria: patients with abdominal abscess, fistula, intestinal active bleeding, or extra‐intestinal manifestations Age (mean ± SD): total cohort: 43.9 (17) years total Sex (M/F): total cohort: 28/22 total Site of disease: NS Use of concurrent medication: All participants were being treated with intravenous biologic therapy (infliximab or vedolizumab). Disease activity: inactive Disease duration: NS Number randomised: NS per IG/CG, 50 in total (CD: 25, UC: 25) Number reaching end of study: NS per IG/CG, 47 in total Number analysed: NS per IG/CG, 47 total Postrandomisation exclusion: 3 |
|
Interventions |
IG: low FODMAP diet CG: high FODMAP/normal diet |
|
Outcomes |
Length of intervention: 8 weeks cross‐over (4 weeks per arm) Primary outcomes: Abdominal pain intensity was measured on a 0‐to‐10‐centimetre VAS at the beginning, at 4 weeks (end of first cross‐over arm), and at 8 weeks (end of second cross‐over arm); it was unclear if this measured pain frequency or intensity or what range was used. 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 | Cohort presented as a whole, more information is needed. We contacted the author but received no response. |
Selective reporting (reporting bias) | Unclear risk | The outcomes mentioned in methods are reported in the results, but there are no pre‐cross‐over data. We contacted the author for this information but received no response. |
Other bias | Unclear risk | There is a difference in baseline pain levels, and conflicts of interest are not clear. We contacted the author but received no response. |