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Table 1 Characteristics of the FODMAPs studies included in the systematic review

From: Does a low FODMAPs diet reduce symptoms of functional abdominal pain disorders? A systematic review in adult and paediatric population, on behalf of Italian Society of Pediatrics

Study Methodology Participants Intervention Duration Outcome measurements and instruments Key results Quality
Bohn 2015 [20] Randomized, single- blind, trial Adults aged 18–70 y (N = 75) IBS Low FODMAPs diet 4 wks Severity of IBS symptoms; Instruments: IBS-SSS 33 (87%) low FODMAP and 34 (92%) traditional IBS diet group completed the study;IBS symptom severity was significantly reduced in both groups compared to baseline; however, the score did not differ between the groups;19 (50%) low FODMAP group and 17 (46%) traditional IBS diet group responded to the interventions High
Chumpitazi 2015 [22] Randomized, double-blind, cross-over study, with wash-out Children aged 7–17 y (N = 33) IBS Low FODMAPs diet 2 days Children pain episodes frequency; Instruments: Pain and Stoll Diary 17 children began with the TACD, and 16 began with the low FODMAP diet; children had fewer daily abdominal pain episodes during the low FODMAP as compared to the TACD dietary intervention [1.1 ± 0.2 vs. 1.7 ± 0.4 pain episodes per day, respectively; P < 0.05]. Moderate
de Roest 2013 [33] Prospective observational study Adults (aged non specified) (N = 90) IBS Low FODMAPs diet 6 wks Improvement of GI symptoms including abdominal pain, bloating, flatulence and diarrhoe; Instruments: GSRS (7-point Likert scale) 90 patients with IBS (47%) completed the whole study. Symptoms significantly improved at follow-up (44% patients with improvement in abdominal pain, 38% in bloating, 38.5% in constipation, 60% in diarrhea). Significant positive correlation between adherence to diet and improvement in individual GI symptoms Low
Escobar 2014 [45] Retrospective study Children and adults aged 2–19 y (N = 222) RAP Low-fructose diet 2 months (not clearly specify) Improvement of abdominal pain; Instruments: Pain scale score 93 of 121 patients with BTH positive (76.9%) reported resolution of symptoms on a low-fructose diet (P < 0.0001) respect to 55 of 101 patients (54.4%) with negative BHT for fructose (P = 0.37). Low
Gijsbers 2012 [42] Prospective study with DBPC test of provocation Children aged 4–16 y (N = 220) RAP Low-lactose and/or fructose diet 3 day of provocation test Disappearance of abdominal pain with elimination, recurrence with provocation and disappearance with re- elimination; Instruments: not specify Pain disappeared upon elimination in 24/38 patients with lactose malabsorption, and in 32/49 with fructose malabsorption. Open provocation with lactose and fructose was positive in 7/23 and 13/31 patients. DBPC provocation in 6/7 and 8/13 patients, was negative in all. However, several children continued to report abdominal symptoms upon intake of milk or fructose. Low
Gomara 2008 [43] Prospective study Children aged 7–17 y (N = 32) FGIDs Low-fructose and low-sorbitol diet 2 months Improvement in their GI symptoms; Instruments: not specify Among the group with positive fructose breath test results, 9 of 11 patients (81%) reported almost immediate improvement in their symptoms; only abdominal pain and bloating were significantly reduced (P < 0.05) Low
Gremse 2003 [41] Randomized, double-blind, cross-over study Children aged 3–17 y (N = 30) RAP and lactose maldigestion Low-lactose diet 2 wks Improvement in their GI symptoms; Instruments: Symptoms Daily Diary Significant increase in abdominal pain experienced by study participants during the lactose ingestion period when compared to the lactose-free period Moderate
Halmos 2014 [28] Randomized, controlled, single-blind, cross-over trial Adults aged 23–60 y (N = 38) IBS Low FODMAPs diet 21 days Improvement in their GI Symptoms; Instruments: Daily symptom scale; VAS 30 IBS participants (91%) and 8 controls (67%) completed the study; 70% IBS subjects had lower overall GI symptom scores on low FODMAP diet compared with typical and subjects’ habitual diet. Similar results with individual symptoms.Bloating, pain, and passage of wind also were reduced while IBS patients were on the low-FODMAP diet, but diarrhea-predominant IBS was the only subtype with altered fecal frequency and King’s Stool Chart scores. Moderate
Houstoft 2016 [31] Randomized Double-blind, placebo controlled, cross-over study Adults aged 18–52 y (N = 20) diarrhea-predominant or mixed IBS Low FODMAPs diet 9 wks Improvements in GI symptoms; Instruments: IBS-SSS There was a significant improvement in all IBS symptoms after 3 weeks of LFD with a mean reduction in IBS-SSS total score of 163.8. When supplementing the LFD with FOS or placebo, significantly more participants reported symptom relief in response to placebo (80%) than FOS (30%; P = .013). Moderate-High
Lebenthal 1981 [40] Prospective study Children aged 6–14 y (N = 69) RAP Low-lactose diet 12 months Improvement in RAP; Instruments: Symptoms Diary After 12 months of elimination diet symptoms of RAP resolved in 6/15 (40%)lactose malabsorbers, 5/13 (38,4%) lactose absorbers and in 5/12 (41.7%) lactose absorbers in regular diet Low
Maagard 2016 [36] Retrospective study Adults aged 18–85 y (N = 180) IBS and IBD Low FODMAP diet 16 months Improvement of symptoms and stool pattern; Instruments: Questionnaire, IBS SSS, stool pattern Eighty-six per cent of patients on LFD reported either partial (54%) or full (32%) efficacy with greatest improvement of bloating (82%) and abdominal pain (71%). After dietary intervention, the proportion of patients producing normal stools increased, with 41% in the IBS group (P < 0.001) Low
Ong 2010 [30] Randomised, single-blind, cross-over study Adults aged 22–68 y (N = 30) IBS low FODMAPs-diet 2 days Improvement of symptoms; Instruments: GI symptoms questionnaire; food diares; breath test All symptoms were significantly worsened with high FODMAP diet in patients with IBS. Dietary FODMAPs induce prolonged hydrogen production in the intestine that is greater in IBS patients Moderate-High
Pedersen 2014 [29] Randomised unblinded controlled trial Adults aged 18–74 y (N = 123) Low FODMAPs diet 6 wks Changes in IBS symptoms and quality of life; Instruments: IBS-SSS and IBS-QoL Overall there was a significant reduction of IBS-SSS mean ± SD in all patients from baseline to week 6, mean IBS-SSS score 77 ± 104, P < 0.01, as well as in each treatment group (LFD, P < 0.001, LGG, P < 0.01 and ND, P = 0.03).At week 6, comparing mean IBS-SSS between all three groups, a statistically significant reduction in the IBS-SSS was observed in LFD and LGG groups compared to the ND group, mean IBS-SSS 133 ± 122 vs 68 ± 107, 133 ± 122 vs 34 ± 95, P < 0.01 Moderate-High
Pedersen 2014 [32] Prospective, uncontrolled pilot study Adults aged 18–74 y (N = 19) IBS Low FODMAPs diet 6 wks Changes in IBS symptoms and quality of life; Instruments: IBS-SSS and IBS-QoL All 19 patients with IBS completed the study.Significant improvement in IBS in control period and following dietary intervention period.Low FODMAP diet further reduced symptoms (11 patients [57%] improved to mild IBS severity). Significant IBS-QoL change during low FODMAP diet period Moderate
Staudacher 2011 [21] Prospective, controlled, study Adults aged 26–50 y (N = 82) IBS Low FODMAPs diet Unclear Improvement of GI symptoms: Instruments: validated IBS Global Improvement Scale (7-point Likert scale); Four statements on satisfaction with symptom response and dietary advice Significantly more patients in the low FODMAP group compared to the standard group reported improvements in bloating (low FODMAP 82% versus standard 49%, P = 0.002), abdominal pain (low FODMAP 85% versus standard 61%, P = 0.023) and flatulence (low FODMAP 87% versus standard 50%, P = 0.001). There were no significant differences in the proportion of patients reporting improvement in constipation between groups. Moderate-Low
Staudacher 2012 [27] Randomized, controlled tiral Adult aged 18–65 y (N = 41) IBS Low FODMAPs diet 4 wks Improvement of GI symptoms; Instruments: symptom diary based on the GI Symptom Rating Scale All 41 patients were included for ITT and 35 in the PP analysis.At follow-up, more patients inthe intervention group reported adequate symptom control with ITT (68% vs 23%) and for PP (81% vs 26%) Moderate
Valeur 2016 [35] Prospective study Adults aged > 18 y (N = 63) IBS Low FODMAPs diet 4 wks Decreased GI symptoms and evaluation of Short-chain fatty acids (SCFAs); Instruments:IBS-SSS Sixty-three patients completed the study. Following the dietary intervention, IBS-SSS scores improved significantly (p < 0.0001). Total SCFA levels were reduced in fecal samples analyzed both at baseline (p = 0.005) and after in vitro fermentation for 24 h (p = 0.013). Low
Wildersmith 2017 [34] Prospective study Adults aged 26-58y (N = 653) FGIDs Low FODMAPs diet 6–8 wks Decreased global symptoms; Instruments: A nonstandard questionnaire on abdominal symptoms (10-point Likert scales) Bowel and dietary habits 237 of 312 (76%) patients completed the studyOver 80% of patients attained adequate global symptom relief; 93 and 96% of patients with fructose or lactose malabsorption, respectively, 85% adequate relief in patients with diarrhea, 96% with bloating, and 51% with constipation Moderate
Wintermeyer2012 [44] Prospective study Children aged 3–14 y (N = 75) RAP Low-fructose and low-sorbitol diet 4 wks Improvement frequency and intensity of abdominal pain; Instruments: nonstandard questionnaire A median decline of weekly pain frequency from 4 (mean 3.64 + 1.6) before diet to 1 (mean 1.46 + 1.4; p < 0.001) under fructose restriction was documented. The intensity of pain decreased from median 6 (mean 5.83 + 2.0) before intervention to median 3 (mean 3.4 + 2.5; p < 0.001) with diet. Several additional life quality-influencing parameters such as daily stool frequency, nausea, problems to fall asleep, missed school days also improved significantly. Moderate
  1. IBS irritable bowel syndrome, RAP recurrent abdominal pain, TACD typical American childhood diet, LFD low FODMAP diet, ITT intention-to-treat, PP per protocol