Table 2.
An overview of clinical trials investigating the impact of B. longum on adults.
| 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 | |||||
| Ulcerative colitis | 16; > 18 y |
B. longum 536, Synergy 1 prebiotic (FOS & inulin) |
2 x 1011, 6 g prebiotic; 2 daily doses; 4 weeks | Sigmoidal scores significantly reduced; β-defensins mRNA significantly reduced; TNF-α & IL1α significantly reduced; Reduced inflammation in biopsies; Regeneration of epithelial tissue |
Furrie et al.152 |
| Crohn’s Disease | 35; > 18 y |
B. longum 536, Synergy 1 prebiotic (FOS & inulin) |
2 x 1011, 6 g prebiotic; 2 daily doses; 6 months | Significant reductions in CD activity indices & histological scores; TNF-α significantly reduced; Mucosal bifidobacteria increased |
Steed et al.153 |
| Ulcerative colitis | 56; > 18 y | B. longum 536 | 2–3 x 1011; 3 daily doses; 8 weeks | Significant decrease in UC disease activity index scores from baseline to week 8; Significant decrease in Rachmilewitz score from baseline to week 8; Significant decrease in Mayo subscore from baseline to week 8; Increased mucosal healing rate |
Tamaki et al.154 (Multicentre) |
| Ulcerative colitis | 90; > 18 y | VSL#3: B. longum, B. breve, B. infantis, L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, S. salivarius subsp. thermophilus, Balsalazide |
9 x 1011, 2.25 g daily; 8 weeks | Significantly increased number of patients in remission; Achieved remission faster |
Tursi et al.155 |
| Ulcerative colitis | 131; > 18 y | VSL#3: B. longum, B. breve, B. infantis, L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, S. salivarius subsp. thermophilus |
3.6 x 1014, daily; 8 weeks | Significantly higher proportion of patients experienced improvement in UCDAI score of at least 50%; Achieved remission faster; Significantly improved rectal bleeding |
Tursi et al.156 (Multicentre) |
| Ulcerative colitis | 147; > 18 y | VSL#3: B. longum, B. breve, B. infantis, L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, S. salivarius subsp. thermophilus |
3.6 x 1012; 2 daily doses; 12 weeks | Significantly higher proportion of patients experienced improvement in UCDAI score of > 50%; Significantly increased number of patients in remission |
Sood et al.157 (Multicentre) |
| Crohn’s Disease | 119; > 16 y | VSL#3: B. longum, B. breve, B. infantis, L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii subsp. bulgaricus, S. salivarius subsp. thermophilus |
9 x 1011; 2 daily doses; 365 d or beginning day 91 until day 365 | Reduced mucosal inflammatory cytokine levels at days 90 & 365 for patients receiving probiotic for 365 d; Lower rate of recurrence among patients receiving probiotic for 365 d |
Fedorak et al.158
NCT00175292 (Multicentre) |
| Irritable bowel syndrome | 50; 18–65 y |
B. longum, L. acidophilus, L. plantarum, L. rhamnosus, B. breve, B. lactis, S. thermophilus |
1 x 1010; daily; 8 weeks | Adequate relief significantly higher; Stool consistency significantly improved; IBS quality of life tended to be higher; Stabilisation of intestinal microbiota |
Ki Cha et al.159 |
| Irritable bowel syndrome | 25; > 18 y |
B. longum BB536, L. rhamnosus HN001, Vitamin B6 |
5 x 109, 1.4 mg; daily; 1 month | Significantly improved abdominal pain, bloating & disease severity; Significantly improved colonic permeability; Increased lactic acid bacteria & bifidobacteria |
Bonfrate et al.160
NCT03815617 |
| Irritable bowel syndrome (diarrhea-dominant) | 80; > 18 y |
B. longum DSMZ 32,946, B. bifidum DSMZ 32,403, B. lactis DSMZ 32,269, L. acidophilus DSMZ 32,418, L. rhamnosus FloraActive™ 19070–2 FOS |
5 x 109, 947 mg; 2 daily doses; 8 weeks | Significant improvement in symptom scores | Skrzydlo-Radomańska et al.161 NCT04206410 |
| Irritable bowel syndrome (IBS-C, IBS-D, IBS-M) | 248; > 18 y | B. longum R0175 | 1 x 1010; daily; 8 weeks | Improved quality of life in emotional wellbeing & social functioning; Increased energy levels that impacted willingness & ability to perform everyday tasks |
Lewis et al.162 NCT02213172 |
| Irritable bowel syndrome | 362; > 18 y | B. infantis 35624 | 1 x 106 or 1 x 108 or 1 x 1010; 4 weeks |
1 x 108 CFU significantly improved abdominal pain, bloating, bowel dysfunction, incomplete evacuation, straining, & flatulence | Whorwell et al.163 |
| Irritable bowel syndrome | 77; > 18 y | B. infantis 35624 | 1 x 1010; 8 weeks | Significant reduction in symptom scores for abdominal pain/discomfort, bloating/distension, & bowel movement difficulty; Normalisation of abnormal IL-10/IL-12 ratio |
O’ Mahony et al.164 |
| Acute-radiation induced diarrhea | 246; > 18 y |
B. longum BB-536, L. acidophilus LAC-361 |
1.3 x 109, 2 daily doses or 1 x 1010, 3 daily doses |
No effect during radiation treatment in non-surgery patients but 1.3 x 109 CFU reduced number of patients with moderate to severe diarrhea after radiation therapy; In surgery patients (before radiation therapy), 1.3 x 109 CFU increased proportion of patients without very severe diarrhea during treatment. |
Demers et al.165
NCT01839721 |
| Constipation | 94; > 18 y |
B. longum UABI-14, B. animalis ssp. lactis UABIa-12, B. bifidum UABb-10, L. acidophilus DDS-1 |
1.5 x 1010, 1 daily dose | Faster normalisation of stool frequency & consistency after 1 week of treatment; Higher relative abundance of Ruminococcaceae & lower relative abundance of Erysipelotrichaceae |
Martoni et al.166 NCT02418507 |
| Lactose intolerance | 23; > 18 y |
B. longum BB536, L. rhamnosus HN001, Vitamin B6 |
5 x 109, 1.4 mg; daily; 1 month | Significantly decreased bloating & improved constipation; Enriched genera involved in lactose digestion; Increased acetic acid, 2-methylpropanoic acid, nonenal, indolizine 3-methyl, decreased phenol |
Vitellio et al.167 NCT03815617 |
| Stress-induced gastrointestinal symptoms | 75; > 18 y | B. longum Rosell-175, L. acidophilus Rosell-52 | 3 x 109; daily; 3 weeks | Significantly reduced abdominal pain & nausea/vomiting | Diop et al.168 |
| Immunity | |||||
| Blood anti-oxidative activity in asymptomatic H. pylori colonised subjects | 53; 20–60 y |
B. longum 46, L. paracasei 8700:2, L. fermentum ME-3, FOS |
3 x 109, 6.6 g, 2 doses daily; 3 weeks | Significantly increased total antioxidative status; Significantly decreased ratio between oxidised & reduced glutathione |
Hütt et al.169 |
| Ulcerative colitis/Inflammatory biomarkers | 22; 18–75 y | B. infantis 35624 | 1 x 1010, daily, 6 weeks | Significantly reduced C-reactive protein Numerically reduced IL-6 |
Groeger et al.170 |
| Chronic fatigue syndrome/Inflammatory biomarkers | 48; 18–65 y | B. infantis 35624 | 1 x 1010, daily, 8 weeks | Significantly reduced C-reactive protein & TNF-α Numerically reduced IL-6 |
Groeger et al.170 |
| Psoriasis/Inflammatory biomarkers | 26; 18–60 y | B. infantis 35624 | 1 x 1010, daily, 8 weeks | Significantly reduced C-reactive protein & TNF-α | Groeger et al.170 |
| Healthy subjects | 35; 18–65 y | B. infantis 35624 | 1 x 1010, daily, 8 weeks | No impact on pro-inflammatory markers | Groeger et al.170 |
| Peritoneal dialysis patients/Inflammatory biomarkers & endotoxin | 39; ≥ 18 y |
B. longum A101, B. bifidum A218, B. catenulatum A302, L. plantarum A87 |
4 x 109, daily; 6 months | Significantly reduced IL-6, TNF-α, IL-5, & endotoxin; Significantly increased IL-10 levels; Preserved residual renal function which significantly declined in the placebo group after 6 months. |
Wang et al.171 |
| Hemodialysis patients/Inflammatory biomarkers, endotoxin, & anti-heat shock protein 70 antibodies | 75; 30–65 y |
B. longum LAF-5, B. lactis BIA 6, B. bifidum BIA 6, L. acidophilus T16 FOS GOS Inulin |
1.35 x 108, 15 g, 4 times daily; 12 weeks |
Significantly decreased pro-inflammatory markers (C-reactive protein & IL-6), endotoxin levels, & anti-heat shock protein 70 antibodies | Haghighat et al.172 IRCT2017041233393N1 |
| Cardiovascular Health | |||||
| Normal or moderately elevated cholesterol | 34; 18–65 y |
B. longum BB536, L. acidophilus 145 in fermented milk drink |
2.7x107 −1x108 (CFU/g) 1.4–2.1x108 (CFU/g) 375 g daily; 4 weeks |
Significantly decreased LDL-cholesterol in those with baseline level of total cholesterol > 190 mg/dl Significantly reduced HDL-cholesterol |
Andrade and Borges,173 |
| Type 2 diabetes | 54; 35–70 y |
B. longum, L. acidophilus, L. casei, L. rhamnosus, L. bulgaricus, B. breve, S. thermophilus |
7 x 109 2 x 109 7 x 109 1.5 x 109 2 x 108 2 x 1010 1.5 x 109, daily; 8 weeks |
Prevented increase in fasting plasma glucose, Significantly reduced serum hs-CRP, Increased plasma levels of glutathione |
Asemi et al.174 |
| Depression, Anxiety, and Cognitive Functioning | |||||
| Healthy/Psychological impact | 55; 30–60 y |
B. longum R0175, L. helveticus R0052 |
3 x 109 daily; 30 d |
Significantly alleviated psychological distress; Significantly reduced urinary cortisol |
Messaoudi et al.175 |
| Low mood for at least 2 y | 79; ≥ 16 y |
B. longum R0175, L. helveticus R0052 |
3 x 109 daily; 8 weeks |
No effect on low mood; No impact on inflammatory biomarkers |
Romijn et al.176
ACTRN12613000438752 |
| Major depressive disorder but on antidepressant drugs | 81; 36.5 ± 8.03 y |
B. longum R0175, L. helveticus R0052 |
≥1010 daily; 8 weeks |
Significant decrease in the Beck Depression Inventory; Significant decrease in kynurenine/tryptophan ratio; Improved appetite |
Kazemi et al.177 (IRCT2015092924271N1) Kazemi et al.178 |
| Healthy/Cognition, Mood, Sleep quality | 38; 18–35 y |
B. longum BL04, L. fermentum LF16, L. rhamnosus LR06, L. plantarum LP01 |
4 x 109 daily; 6 weeks | Significantly improved mood & sleep quality; Reduced depressive mood state, anger, & fatigue |
Marotta et al.179 NCT03539263 |
| IBS/Mild to moderate depression & anxiety | 44; 26–58 y | B. longum NCC3001 | 1 x 1010 daily; 6 weeks | Significantly reduced depression scores; Significantly improved general physical health; Decreased brain responses to negative emotional stimuli based on fMRI analysis |
Pinto-Sanchez et al.180 NCT01276626 |
| Alzheimer’s disease/Cognitive functions & Metabolic status | 79; 68–84.3 y |
B. longum, B. bifidum, L. acidophilus & selenium |
2 x 109 2 x 109 2 x 109 200 μg daily; 12 weeks |
Significantly improved cognitive function; Significantly reduced hs-CRP, insulin levels, homeostasis model of assessment-insulin resistance, serum triglycerides; Significantly increased total antioxidant capacity, the quantitative insulin sensitivity check index; Significantly improved cholesterol profiles |
Tamtaji et al.181 IRCT20170612034497N5 |
| Respiratory Health and Seasonal Allergies | |||||
| Japanese cedar pollinosis during pollen season | 44; 22–57 y | B. longum BB536 | 5 x 1010; twice daily; 13 weeks | Significantly relieved symptoms; Significantly modulated Th2-skewed immune response; Suppressed Bacteroides fragilis levels in faecal microbiota |
Xiao et al.182 Odamaki et al.183 |
| Japanese cedar pollen exposure in environmental exposure unit | 24; 25–56 y | B. longum BB536 | 5 x 1010; twice daily; 4 weeks | Significantly reduced ocular symptom scores; Reduced disruption of normal activities following exposure; Significantly reduced total medications to alleviate symptoms |
Xiao et al.184 |
| Seasonal allergies during allergy season | 173; 27 ± 1 year |
B. longum MM2, B. bifidum G9–1, L. gasseri KS-13 |
3 x 109; daily; 8 weeks | Significantly improved rhinoconjunctivitis-specific quality of life | Dennis-Wall et al.185 NCT02349711 |
| Perennial allergic rhinitis | 95; 19–65 y |
B. longum IM55, L. plantarum IM76 |
1 x 1010; daily; 4 weeks | Significantly reduced total nasal symptom scores & rhinorrhea Numerically reduced sneezing & nasal congestion Significantly improved anti-allergic immunological profiles |
Kang et al.186 KCT0003760 |
| Common cold | 454; adults |
B. longum SP 07/3, B. bifidum MF 20/5, L. gasseri PA 16–8 |
5 x 107; daily; 3 months & 5.5 months (two different study groups) | Shortened common cold episodes by at least two 2 d & reduced severity of symptoms; After 14 d of supplementation, CD4+ T helper cells increased & cytotoxic plus T suppressor cells (CD8+) significantly increased |
De Vrese et al.187 |
| Skin | |||||
| Reactive skin | 66; healthy females | B. longum lysate | 10% lysate applied to skin twice daily; 2 months | Significantly decreased skin sensitivity; Reduced skin dryness |
Guéniche et al.188 |