Table 6.
Examples of clinical trials regarding the effect of synbiotics on human health.
| References | Subjects | Composition of Synbiotic | Time of Administration | Main Outcome |
|---|---|---|---|---|
| Obesity | ||||
| [193] | 153 obese men and women | L. rhamnosus CGMCC1.3724, inulin | 36 weeks | Weight loss and reduction in leptin. Increase in Lachnospiraceae. |
| [194] | 70 children and adolescents with high BMI | L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, FOS | 8 weeks | Decrease in BMI z-score and waist circumference. |
| [195] | 77 obese children | L. acidophilus, L. rhamnosus, B. bifidum, B. longum, E. faecium, FOS | 4 weeks | Changes in anthropometric measurements. Decrease in TC, LDL-C, and total oxidative stress serum levels. |
| Insulin resistance syndrome | ||||
| [196] | 38 subjects with IRS | L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, FOS | 28 weeks | The levels of fasting blood sugar and insulin resistance improved significantly. |
| Type 2 diabetes | ||||
| [197] | 54 patients with T2D | L. acidophilus, L. casei, L. rhamnosus, L. bulgaricus, B. breve, B. longum, S. thermophilus, FOS | 8 weeks | Increased HOMA-IR and TGL plasma level; reduced CRP in serum. |
| [198] | 81 patients with T2D | L. sporogenes, inulin | 8 weeks | Significant reduction in serum insulin levels, HOMA-IR, and homeostatic model assessment cell function. |
| [199] | 78 patients with T2D | L. sporogenes, inulin | 8 weeks | Decrease in serum lipid profile (TAG, TC/HDL-C) and a significant increase in serum HDL-C levels. |
| [200] | 20 patients with T2D | L. acidophilus, B. bifidum, oligofructose | 2 weeks | Increased HDL-C and reduced fasting glycaemia. |
| Non-alcoholic fatty liver disease | ||||
| [187] | 20 individuals with NASH | L. plantarum, L. delbrueckii spp. bulgaricus, L. acidophilus, L. rhamnosus, B. bifidum, inulin | 26 weeks | Decreased IHTG content. |
| [188] | 52 adult individuals with NAFLD | L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. longum, L. bulgaricus, FOS | 30 weeks | Inhibition of NF-κB and reduction of TNF-α. |
| Irritable bowel syndrome (IBS), gastrointestinal disorders, elimination of Helicobacter, inflammatory bowel disease (IBD), diarrhoeas | ||||
| [201] | 76 patients with IBS | L. acidophilus La-5®, B. animalis ssp. lactis BB-12®, dietary fibres (Beneo) | 4 weeks | On average, an 18% improvement in total IBS-QoL score was reported and significant improvements in bloating severity, satisfaction with bowel movements, and the severity of IBS symptoms’ interference with patients’ everyday life were observed. However, there were no statistically significant differences between the synbiotic group and the placebo group. |
| [202] | 69 children aged 6–16 years who had biopsy proven H. pylori infection | B. lactis B94, inulin | 14 days | From a total of 69 H. pylori-infected children (female/male = 36/33; mean ± SD = 11.2 ± 3.0 years), eradication was achieved in 20 out of 34 participants in the standard therapy group and 27/35 participants in the synbiotic group. There were no significant differences in eradication rates between the standard therapy and the synbiotic groups. |
| [203] | 40 patients with UC | B. longum, psyllium | 4 weeks | Patients with UC on synbiotic therapy experienced greater quality-of-life changes than patients on probiotic or prebiotic treatment. |
| Atopic dermatitis | ||||
| [204] | 90 infants with AD | B. breve M-16V, GOS and FOS mixture (Immunofortis®) | 12 weeks | This synbiotic mixture did not have a beneficial effect on AD severity in infants, although it did successfully modulate their intestinal microbiota. |
| [205] | 40 infants and children aged 3 months to 6 years with AD | L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis, L. bulgaricus, FOS | 8 weeks | A mixture of seven probiotic strains and FOS may clinically improve the severity of AD in young children. |
| Alleviation of lactose intolerance | ||||
| [206] | 20 females and males | Lactobacillus, Bifidobacterium, FOS | 5 weeks | Consumption of the probiotic mixture improved the gastrointestinal performance associated with lactose load in subjects with LI. Symptoms were additionally reduced by the addition of prebiotics. The supplementation was safe and well tolerated, with no significant adverse effect observed. |
| Different types of cancer and side effects associated with cancer | ||||
| [192] | 43 polypeptomized and 37 colon cancer patients | L. rhamnosus GG, B. lactis Bb12, inulin | 12 weeks | Increased L. rhamnosus and B. lactis in faeces, reduction in C. perfringens, prevents increased secretion of IL-2 in polypectomized patients, increased production of interferon-γ in cancer patients. |
Abbreviations: BMI—body mass index; CFU—colony-forming-unit; CRP—C-reactive protein; FOS—fructo-oligossacharides; IBS-QoL—quality of life with IBS; HDL-C—high-density lipoprotein cholesterol; HOMA-IR—homeostasis model assessment of insulin resistance; IHTG—intrahepatic triacylglycerol; IRS—insulin resistance syndrome; LDL-C—low-density lipoprotein cholesterol; LI—lactose intolerance; NAFLD—non-alcoholic fatty liver disease; NF-κB—nuclear factor κB; T2D—type 2 diabetes; TAG—triacylglycerols; TC—total cholesterol; TGL—total glutathione levels; TNF-α—tumour necrosis factor α; UC—ulcerative colitis.