Table 1.
General characteristics of RCTs studying probiotics in paediatric FAPD
| First author (year), country | Number of participants (age range) | Recruiting criteria (diagnosis) | Length of trial (weeks) | Intervention | Control | Dose/day | Primary outcome | Authors conclusion |
|---|---|---|---|---|---|---|---|---|
| Giannetti (2017), Italy | 73 (8–18) | Rome III (IBS, FD) | 6 | 3 billion Bifidobacterium (B). longum, 1 billion B. infantis, 1 billion B. breve | Placebo | once | AP resolution | Improvement in AP and QoL in IBS but not confirmed in FD. |
| Jadrešin (2017), Croatia | 55 (5–17) | Rome III (IBS, FAP) | 12 | Lactobacillus (L). reuteri DSM 17938 | Placebo | Once | Days without pain and pain change during the study period | May reduce intensity of pain; more days without pain in FAP and IBS. |
| Maragkoudaki (2017), Greece | 54 (5–16) | Rome III (FAP) | 4 | L. reuteri DSM 17938 108, 2 tablets | Placebo | Once | Pain frequency and intensity | Probiotics not superior to placebo in FAP. |
| Weizman (2016), Israel | 101 (6–15) | Rome III (FAP) | 4 | L. reuteri 17938 1 × 108 CFU | Placebo | Once | Frequency and intensity of AP | Reduced frequency and intensity of FAP. |
| Eftekhari (2015), Iran | 80 (4–16) | Rome III (FAP) | 4 | L. reuteri 17938 1 × 108 CFU, | Placebo | Once | Pain intensity, pain frequency, and response to treatment | Probiotics were not superior to placebo in FAP. |
| Kianifar (2015), Iran | 52 (4–18) | Rome III (IBS) | 4 | Oral LGG (1 × 1010 CFU) with inulin | Inulin | Twice | Severity of AP | LGG resulted in reductions in the severity of AP. |
| Romano (2014), Italy | 60 (6–16) | Rome III (FAP) | 8 | Oral L. reuteri 17938 (1 × 108 CFU), | Placebo | Twice | Reduction in intensity of FAP | Reduced intensity, but not frequency of AP. |
| Francavilla (2010), Italy | 141 (5–14) | Rome II (IBS, FAP) | 8 | Oral LGG (3 × 109 CFU) | Placebo | Twice | Change in AP (frequency/severity) | Reduced frequency and severity of pain in children with IBS. |
| Guandalini (2010), Italy/ India | 59 (4–18) | Rome II (IBS) | 6 | VSL #3 (450 × 109 bacteria/sachet) | Placebo | 1 sachet once (age 4–11); 2 sachets twice (age 12–18) | Sobject’s global assessment of relief (SGARC) | Decreased severity and frequency of AP, abdominal bloating; improved QoL. |
| Gawrońska (2007), Poland | 104 (6–16) | Rome II (IBS, FAP, FD) | 4 | Oral LGG (3 × 109 CFU) | Placebo | Twice | Treatment success (no pain at the end of intervention) | Improved treatment success on IBS, with no effect on IBS or FD. |
| Bauserman (2005), USA | 50 (6–17) | Rome II (IBS) | 6 | Oral LGG (1 × 1010 CFU) with inulin | Placebo with inulin | Twice | Change in AP severity score | Did not improve AP; may help improve symptoms such as perceived abdominal distension. |
Rome II and Rome III definition can be found in Appendix III.AP Abdominal pain; CFU Colony forming units; FAP Functional abdominal pain; FD Functional dyspepsia; FGID Functional gastrointestinal disorder; IBS Irritable bowel syndrome; LGG = Lactobacillus (L) rhamnosus GG; QoL Quality of life; VSL = Bifidobacterium (B) breve, B.longum, B. infantis, L. acidophilus, L. planatarum, L. casei, L. bulgaris, Streptococcus thermophiles; 450 billion CFU per sachet.