Table 1.
An overview of clinical trials investigating the impact of B. longum on infants and children.
| Condition/Disease/Biological Parameter | Participants; Age | Formulation | CFU; Dose; Duration | Clinical Effects and Biological Observations of Intervention Group Compared with Placebo Group | Reference; Trial ID |
|---|---|---|---|---|---|
|
Gastrointestinal Conditions | |||||
| Late onset sepsis | 1099; Very preterm infants (<1500 g) |
B. longum ssp. infantis BB02, S. thermophilus TH-4, B. animalis ssp. lactis BB-12 |
109; 2 daily doses until hospital discharge or term corrected age | Significant reduction in NEC of Bell stage 2 or more; No reduction in definite late-onset sepsis or all-cause mortality |
Jacobs et al.72 ACTRN012607000144415 (Multicentre) |
| Time to reach full enteral feeds in very low birth-weight newborns | 104; Very Low Birth Weight (75–1499 g) |
B. longum, L. acidophilus, L. rhamnosus, S. boulardii |
1.25 x 109; 1 daily dose, From initiation of enteral feeds till hospital discharge |
Trend towards reduced NEC; No impact on feed tolerance |
Shashidhar et al.74 CTRI/2012/08/002853 |
| Gastroschisis | 24; Gestational age at birth > 34 weeks | B. longum ssp. infantis ATCC 15,697 | 109; 2 daily doses for 6 weeks or until hospital discharge | Higher Bifidobacteriaceae, lower Clostridiaceae; Trend towards lower Enterobacteriaceae, Enterococcaceae, Staphylococcaceae, & Streptococcaceae; No impact on length of hospital stay |
Powell et al.77
NCT01316510 |
| Diarrhea | 151; Term infants (< 3 months) | B. longum ssp. infantis CECT7210 | 107; daily, 12 weeks | Significantly reduced diarrhoea episodes at week 8 | Escribano et al.83
NCT02096302 (Multicentre) |
| Rotavirus disease | 57; 9–16 months |
B. longum BORI, L. acidophilus AD031 |
2 x 1010 B. longum, 2 x 109 L. acidophilus; 2 daily doses, 3 d | Significantly reduced duration of diarrhoea (by 1.2 d); Tended to ameliorate duration of fever, frequencies of diarrhoea & vomiting |
Park et al.84 |
| Irritable bowel syndrome | 48; 8–17.9 y |
B. infantis M-63, B. longum BB536, B. breve M-16V |
3 x 109
B. longum, 1 x 109 B. infantis,1 x 109 B. breve; 6 weeks |
Resolution of abdominal pain in significantly higher number of children; Significantly improved frequency of abdominal pain; Improvement in Quality of Life significantly higher |
Giannetti et al.86
NCT02566876 (Multicentre) |
| Ulcerative colitis | 29; 1.7–16.1 y | VSL#3: B. longum, B. breve, B. infantis, L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, S. salivarius subsp. thermophilus |
4.5 x 1011−1.8 x 1012 (age-dependent); 1 year | Significant efficacy for inducing & maintaining remission | Miele et al.88 |
| Immunity | |||||
| Immunity & Gut microbiota composition | 264; healthy term newborns | B. longum BB536 | 1 x 107; 12 months | Significantly elevated levels of IF-γ secretion cells; Ratio of IF-γ/IL-4 secretion cells significantly higher; Faecal bifidobacteria counts & bifidobacteria/Enterobacteriaceae ratio significantly higher |
Wu et al.89 |
| Severe sepsis & levels of pro- & anti-inflammatory cytokines | 100; 3 months to 12 y | VSL#3: B. longum, B. breve, B. infantis, L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, S. salivarius subsp. thermophilus |
4.5 x 1011; 7 d | Significant decrease in pro-inflammatory cytokines; Significant increase in anti-inflammatory cytokines; Significant reduction in Sequential Organ Failure Assessment score; Lower incidence of healthcare-associated infections; Reduced duration of stay in intensive care unit |
Angurana et al.90 |
| Cardiovascular Health | |||||
| Dyslipidaemia | 38; 10.8 ± 2.1 y |
B. longum ssp. longum BL04, B. animalis ssp. lactis MB 2409, B. bifidum MB 109B |
3 x 109, daily; 3 months | Significantly reduced total cholesterol & LDL-cholesterol | Guardamagna et al.91 |
| Developmental Disorders | |||||
| Autism spectrum disorder | 26; 4–5 y |
B. infantis Bi-26, L. rhamnosus HN001, B. lactis BL-04, L. paracassei LPC-37, & FOS |
1010 daily; 108 d |
Significantly increased beneficial bacteria when compared with baseline; Significantly reduced levels of suspected pathogens; Significantly increased SCFA & homovanillic acid; Significantly reduced serotonin; Improved gastrointestinal autism severity |
Wang et al.92 |
| Respiratory Health and Seasonal Allergies | |||||
| Common winter diseases | 135; 3–7 y |
B. infantis R0033, B. bifidum R0071, L. helveticus R0052, FOS |
3 x 109 750 mg; once daily; 3 months |
Reduced the number of children who suffered at least one winter disease by 25% & limited the number of school days lost | Cazzola et al.93 |
| Upper respiratory illnesses | 219; 2–6 y | B. longum BB536 | 5 x 109; 5 d/week for 10 months | Significantly reduced duration of sore throat; Numerically reduced duration of runny nose & cough; Increased Faecalibacterium in gut microbiota |
Lau et al.94 NCT02434042 |
| Seasonal allergic rhinitis & intermittent asthma | 40; 9 ± 2.2 y |
B. longum BB536, B. infantis M-63, B. breve M-16V |
3 x 109 1 x 109 1 x 109; once daily; 8 weeks |
Significantly relieved nasal symptoms of allergic rhinitis & improved quality of life | Miraglia Del Giudice et al.95 NCT02807064. |
| Skin Health | |||||
| Eczema development in at-risk infants | 241 pregnant women. Supplementation began 2 months before delivery and during first 2 months of breast feeding. 205 infants assessed |
B. longum BL999, L. rhamnosus LPR or B. longum BL999, L. paracasei ST11 |
1 x 109 daily; 4 months | Both formulations significantly reduced the risk of developing eczema in at-risk infants | Rautava et al.96 |
| Eczema development in at-risk infants | 245 Infants; newborn |
B. longum BL999, L. rhamnosus LPR |
~9 x 107 ~ 2 x 108; daily; 6 months |
No impact | Soh et al.97 |
| Moderate atopic dermatitis | 50; 4–17 y |
B. longum CECT 7347, B. lactis CECT 8145, L. casei CECT 9104 |
1 x 109 daily; 12 weeks | Significantly reduced SCORAD & reduced eczema spread & intensity | Navarro-López et al.98 NCT02585986 |