Table 2 Use of Bifidobacterium in clinical trials
Type of studyNo. of subjectsAgeCharacteristics of subjectsProbiotic strainMedication?Intervention timeColonisation?Main outcomeRef.
RDBPCT1824–67 yearsPatients with active UCB. longum (2 × 1011 CFU) plus 6 g Synergy 1Yes — steroids (10), immunosuppressants (12), 5-ASA (10)Twice daily for 28 daysqPCR on biopsiesShort-term treatment improved the full clinical appearance of chronic inflammation in patients with active UC. Reduction in mRNA of TNF-α in the Bif treatment group[73]
RCT12036 ± 16 years (mean)Patients on remission or with mildly active UC without a history of operation for UCB. longum (2 × 109 CFU) plus 4 g psylliumYes — aminosalicylates and/or prednisoloneTwice daily for 28 daysNo dataReduction in CRP in synbiotic compared with Bif and prebiotic-only groups. Synbiotic treatment improved the quality of life better than Bif or prebiotic treatment based on patient questionnaires[81]
RDBPCT3518–79 yearsPatients with active CDB. longum (2 × 1011 CFU) plus 6 g Synergy 1Yes — steroids (9), 5-ASA (14), azathioprine (6), mercaptopurine (1), elemental (1) PPI (1)Twice daily for 183 daysqPCR on biopsiesBif group had reduction in CD activity index and histological scores and reduction in TNF-α[82]
RCT4145.5 (mean)Patients with mild-to-moderate UCB. breve strain Yakult (1 × 109 CFU) plus 5.5 g GOSYes — salazosulfapyridine, 5-ASA, steroidsOnce daily for 365 daysBacterial countsA significant reduction in endoscopy score after treatment in the synbiotic group. Not difference in the endoscopy score between control and synbiotic treatment[83]
RDBPCT2218–75 yearsPatients with mild-to-moderate UC and CAIA ≥3B. longum subsp. infantis 35 264 (1 × 1010 CFU)Yes — 5-ASA (22)Once daily for 6 weeksNo dataReduction in plasma CFP and IL-6 levels in the Bif group compared with placebo (no significant reduction compared with pre-treatment)[70]
RDBPCT5644 ± 14 years (mean)Patients with mild-to-moderate UC and CAIA ≥3–9B. longum 536 (2–3 × 1011 CFU)Yes — 5-ASA (53), prednisolone (17), azathioprine (14)Three times daily for 8 weeksNo dataReduction in UCDAI score compared with baseline in the Bif treatment group. No significant difference in UCDAI scores between placebo and control following treatment. A significant decrease in EI score in the Bif group when compared with baseline[84]
RDBPCT271.3–2.0 monthsManifested atopic eczema during exclusive breast-feeding and who had no exposure to any infant or substitute formulaInfant formula supplemented with B. lactis Bb-12 (1 × 109 CFU/g)N/AAd libitum for 2 monthsNo dataStatistically significant reduction on SCORAD score in B. lactis Bb12 group[85]
RDBPCT507–24 monthsDiagnosed with atopic dermatitisB. lactis Bi-07 (1 × 1010 CFU)N/AOnce daily for 8 weeksYesProbiotic administration did not alter the composition of the microbiota, but an increase in B. lactis correlated with decreased SCORAD index, but could not be attributed to probiotic consumption[86]
RDBPCT2083–6 monthsPhysician diagnosed ezcemaB. lactis CNCM I-3446 (1 × 1010 CFU)Before supplementation 1% hydrocortisone ointment 2×/day, emollients/moisturisers 2–49/day, bath emollientOnce daily for 3 monthsYesNo benefit from supplementation with either bacteria compared with placebo[87]
RDBPCT75Infants <7 monthsPositive for atopic dermatitisWhey formula containing B. breve M-16V (1.3 × 109 CFU/100 ml) + 90% scGOS + 10% lcFOS, 0.8 g/100 mlTopical steroidsOn demand for 12 weeksNo dataReduced asthma like symptoms and no. of subjects requiring asthma medication 1 year following Bif treatment compared with placebo[88]
RDBPCT7718–75 yearsPatients who satisfied Rome II criteria for IBS diagnosisB. infantis 35 624 (1 × 1010 CFU)N/AOnce daily for 8 weeksYesReduction in symptoms for Bif group. Normalised IL-10/IL-12 ratio when treated with Bif[89]
RDBPCT362Women with bowel habit subtypeB. infantis 35 624 (1 × 106 or 1 × 108 CFU)N/AOnce daily for 4 weeksReduction in symptom in 108 CFU/ml Bif group compared with the placebo group[90]
RDBPCT12218–68Mild-to-moderate IBS (Rome III criteria)B. bifidum MIMBb7 (1 × 109)N/AOnce daily for 4 weeksNoReduction in symptoms in the Bif treatment group[91]

Abbreviations: RDBPCT, randomised; double-blind; placebo-controlled trial; RCT, randomised clinical trial; UC, ulcerative colitis; CD, Crohn's disease; Bif, Bifidobacterium supplemented; CAIA, clinical activity index assessment; GOS, galactooligosaccharide; scGOS, short-chain galactooligosaccharides; lcFOS, long-chain fructooligosaccharides; 5-ASA, 5-aminosalicylic acid; PPI, protein pump inhibitor; CRP, C-reactive protein.