TABLE 3.
Therapeutic trials in IBS human subjects with probiotic supplements: experimental design, effectiveness, and side effects1
| Study (reference) | Study design | Subjects | Probiotic's synthesis | Substrate | Effectiveness | Side effects |
|---|---|---|---|---|---|---|
| Koebnick et al., 2003 (82) | Double-blind placebo-controlled randomized trial | 35 active; 35 placebo; 18–65 y; males and females | Lactobacillus casei Shirota | Beverage (65 mL/d) | Significant improvement in constipation and stool consistency | No side effects |
| Niv et al., 2005 (83) | Double-blind placebo-controlled randomized trial | 54 included/39 completed; 19–70 y; males and females | Lactobacillus reuteri ATCC 55,730 | Capsule (1 × 108 CFU) | No symptom improvement | Several side effects |
| Whorwell et al., 2006 (84) | Double-blind placebo-controlled randomized trial; multicenter dose ranging | 362 females, 270 active group/92 placebo group; 18–55 y; males and females | Bifidobacterium infantis 35,624 | Lyophilized capsule (1 × 106, 1 × 108, 1 × 1010 CFU/mL) | B. infantis (1 × 108 CFU) improved the symptoms of IBS, such as abdominal pain, bloating, bowel dysfunction, and incomplete emptying | 17 (<5%) of the 362 patients reported adverse effects and withdrew from the study |
| Sinn et al., 2008 (85) | Double-blind placebo-controlled randomized trial | 20 active group/20 placebo group; 18–65 y | Lactobacillus acidophilus-SDC 2012, 2013 | Lyophilized capsules (2 × 109 CFU/mL) | Improvement in abdominal pain and discomfort | No side effects |
| Guglielmetti et al., 2011 (86) | Double-blind placebo-controlled randomized trial | 60 active group/62 placebo group; 18–68 y; males and females | Bifidobacterium bifidum MIMBb75 | Uncovered capsule (1 × 109 CFU) | GI symptom relief: pain, discomfort, dilation, bloating, digestive disorders, QoL improvements | 23/60 patients reported abdominal distension, abdominal pain, diarrhea, nausea, constipation |
| Ducrotté et al., 2012 (87) | Double-blind placebo-controlled randomized trial | 214; 18–70 y; males and females | Lactobacillus plantarum 299v (DSM 9843) | Lyophilized capsule (1 × 1010 CFU) | Pain reduction, daily frequency, and bloating in patients | No side effects; only 1 patient mentioned transient vertigo |
| Niedzielin et al., 2001 (88) | Multicenter double-blind, placebo-controlled study with parallel groups | 108 active group/106 placebo group; males and females | Lactobacillus plantarum 299V (LP299V) | Fermented fruit juice with 5% oats | Symptom improvement in 95% of the IBS patients | No side effects |
| Murakami et al., 2012 (89) | Double-blind cross-matched trial | 35 males and females >6 y | Lactobacillus brevis KB290 | Lyophilized capsule (1 × 1010 CFU) | Improvement in IBS symptoms; increased abundance of Bifidobacterium and Clostridium in the intestinal microflora | Side effects: abdominal pain and diarrhea |
| Stevenson et al., 2014 (90) | Double-blind placebo-controlled randomized trial | 54 active group/27 placebo group; 96% females | Lactobacillus plantarum 299V (LP299V) | Capsule (5 × 109 CFU) | No relief in patients from abdominal pain | Several side effects/not described in detail |
| Pineton de Chambrun et al., 2015 (91) | Double-blind placebo-controlled randomized trial | 86 active group/93 placebo group | Saccharomyces cerevisiae | Capsule (8 × 109 CFU/g) | Improvement only in abdominal pain and discomfort | Side effects included diarrhea, constipation, headache, abdominal pain, bloating, back pain, gastroesophageal reflux disease, bladder infection, influenza, and hemorrhoidal crisis |
| Thijssen et al., 2016 (92) | Double-blind placebo-controlled randomized trial | 39 active group/41 placebo group; males and females | Lactobacillus casei Shirota | Fermented milk with L. casei Shirota (6.5 × 109 CFU) | No improvement during intervention; positive effect after completion | No side effects |
| Spiller et al., 2016 (93) | Double-blind placebo-controlled randomized trial | 192 active group/187 placebo group; 18–75 y; males and females | Saccharomyces cerevisiae CNCM I-3856 | Capsule (500 mg) | No overall benefit in IBS; improvement in abdominal pain, discomfort, bloating | Several side effects/not described in detail |
| Sadrin et al., 2017 (94) | Double-blind placebo-controlled randomized trial | 40 active/40 placebo; 18–65 y | Lactobacillus acidophilus NCFM και LAFTI L10 | Capsule (2,5 × 109 CFU) | Reduced abdominal pain; overall improvement of IBS symptoms | Several side effects/not described in detail |
1ATCC, American Type Culture Collection; GI, gastrointestinal; IBS, irritable bowel syndrome; QoL, quality of life.