Table 3.
Results after intervention.
| Low FODMAP Diet | Control Group | |||
|---|---|---|---|---|
| Provocation | After FODMAP | After Placebo | p | After 4 Weeks |
| Guessed the blinding status | 5 (56%) | 3 (33%) | >0.99 | - |
| Self-reported adherence to diet | 9 (100%) | 9 (100%) | - | - |
| Supplementary intake (median (IQR)) % | 86% (74; 95) | 93% (86; 100) | 0.40 | |
| Medication changes * | 1 (11%) | 0 (0.0%) | - | 0 (0.0%) |
| Secondary endpoints, Median (IQR) | ||||
| Weight: kg, % | −2.0 (−3.1; −0.9) | −1.0 (−2.3; −0.5) | 0.30 | 0.0 (−0.5; 0.2) |
| Change in Bristol Stool Scale score? | −0.3 (−1.0; 0.3) | −0.1 (−0.5; 0.0) | 0.30 | 0.3 (−0.2; 0.5) |
| Change in stool frequency/day | 0.0 (−0.9; 0.4) | −0.2 (−0.6; 0.0) | 0.20 | 0.3 (0.2; 0.5) |
| Change in GSRS score | −6 (−17; −3) | −7 (−11; −1) | 0.19 | −4 (−7; −0) |
| Change in SF-36 score | 3.2 (1.1; 7.5) | 2.2 (−3.5; 4.3) | 0.24 | −5.7 (−10.3; 0.3) |
| Change in HADS score | −2 (−6; −2) | 0 (−4; 0) | 0.03 | 0 (−2; 2) |
| Change in VSI score | 6 (3; 11) | −1 (−6; 7) | 0.29 | −3 (−4; 3) |
| Change in AR: No to Yes, % Yes to No, % |
3 (33%) 0 (0.0%) |
3 (33%) 0 (0.0%) |
1.00 | 0 (0.0) 3 (42.9) |
| Change in PHQ15 | −4 (−5; −2) | −4 (−4; −1) | 0.67 | 0 (−4; 2) |
| Change in FODMAPS in diet registration, % | ||||
| Index for all FODMAPs | −49% (−71; −37) | −74% (−78; −36) | 0.81 | 33% (2%; 49%) |
| Fructose | −38% (−49; −30) | −58% (−67.5; −20) | 1.00 | −13% (−29%; 37%) |
| Lactose | −96% (−99; −80) | −99% (−99; −94) | 1.00 | 166% (141%; 287%) |
| Sorbitol | −58% (−93; 147) | −91% (−100; 44) | 0.06 | −34% (−54%; 81%) |
| Mannitol | −22% (−67; −17) | −28% (−50; 9.1) | 1.00 | 200% (−10%; 325%) |
| Fructans | −32% (−47; −29) | −31% (−50; −31) | 0.81 | 0% (−26%; 23%) |
| GOS | −43% (−70; −23) | −40% (−52; −20) | 0.63 | −3% (−19%; 7%) |
| Change in FODMAPS in frequency registration, % | ||||
| Fructose | −30% (−73; 39) | −93% (−97; −90) | 0.06 | −15% (−52%; 166%) |
| Lactose | −100% (−100; −66) | −100% (−100; −57) | 0.58 | −7% (−28%; 96%) |
| Sorbitol | −83% (−92; −77) | −97% (−100; −80) | 0.69 | 20% (−25%; 196%) |
| Mannitol | −98% (−100; −37) | −100% (−100; −86) | 0.42 | −35% (−66%; 24%) |
| Fructans | −90% (−96; −56) | −89% (−93; −76) | 0.56 | 1% (−10%; 39%) |
| GOS | −83% (−98; −37) | −54% (−84; −13) | 0.69 | −1% (−33%; 5%) |
Abbreviations: FODMAPS: Fermentable oligo-, di, and monosaccharides and polyols; n: Number; m: men; w: Women; IQR: Inter-quartile range; UC: Ulcerative colitis; SCCAI: Simple Clinical Colitis Activity Index; 5-ASA: 5-Aminosalicylates; IBS-SSS score: Irritable bowel symptom severity score; GSRS: IBS-specific Gastrointestinal Symptom Rating Scale; SF-36: Short Form 36 Health Survey; HADS: Hospital Anxiety and Depression Scale; VSI: The Visceral Sensitivity Index; AR: Irritable Bowel Syndrome Adequate Relief; PHQ15: Patient Health Questionnaire; GOS; GalactoOligoSaccharide. * started 5-ASA treatment during FODMAP provocation.