Table 2.
Use of B. lactis HN019™ as single-strain products in human clinical trials for gut health.
| Dose (CFU/day) | Subjects (N) in HN019 arm | Age (meana, years) | Duration (week) | Product format | Endpoints | Reference |
|---|---|---|---|---|---|---|
| High dose: 1 × 1010
Low dose: 1 × 109 |
152 Adult constipation |
18–70 (41.7) | 4 | Capsule | CTT, BMF, SC | (22) |
| 1 × 109 | 7 Young female with constipation |
>18 (NR) | 2 | Sachet | BMF, SC | (23) |
| High dose: 1.72 × 1010
Low dose: 1.8 × 109 |
66 Adult constipation |
25–65 (44 in high dose, 44 in low dose) | 2 | Capsule | WGTT, BMF | (32) |
| 5 × 109 | 130 Healthy preschool children |
2–4 (38 months) | 9 months | Capsule | Incidence and duration of diarrhea | (24, 25) |
| High dose: 5 × 109
Medium dose: 1 × 109 Low dose: 6.5 × 107 |
60 Healthy elderly |
60–87 (67 in high dose, 70 in medium/dose) | 4 | Reconstituted milk | Fecal microbiota | (58) |
| 3 × 1010 | 10 Healthy adults |
20–60 (NR) | 4 | Reconstituted milk | Fecal microbiota | (59) |
BMF, bowel movement frequency; CFU, colony forming unit; CTT, colonic transit time; IBS-C, constipation dominant irritable bowel syndrome; CRC, colorectal cancer; FC, functional constipation; NR, not reported; SC, stool consistency; WGTT, whole gut transit time.
a
Mean or Median.