Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial
Abstract
:1. Introduction
2. Subjects and Methods
2.1. Study Population
2.2. Study Design
2.3. Study Product
2.4. Outcome Assessments
2.5. Statistical Analysis
3. Results
3.1. Study Parameters
3.2. Baseline Characteristics of Subjects
3.3. Abdominal Pain Severity
3.4. IBS Symptomology
3.5. Bowel Habits
3.6. Quality of Life, Perceived Stress and Product Tolerability
4. Discussion
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Placebo (n = 109) | L. acidophilus DDS-1 (n = 111) | B. lactis UABla-12 (n = 110) | p Value | |
---|---|---|---|---|
Mean (SD) or n (%) | Mean (SD) or n (%) | Mean (SD) or n (%) | ||
Age (years) | 37.61 (10.12) | 39.41 (11.80) | 41.60 (11.11) | 0.028 ‡ |
Female gender, n (%) | 54 (49.5) | 58 (52.3) | 51 (46.6) | 0.681 † |
BMI (kg/m2) | 24.10 (4.06) | 24.09 (4.34) | 23.78 (3.98) | 0.811 ‡ |
Systolic BP (kPa) | 15.89 (1.13) | 15.96 (1.08) | 16.03 (1.11) | 0.660 § |
Diastolic BP (kPa) | 10.09 (0.94) | 10.33 (0.86) | 10.25 (1.00) | 0.116 § |
Pulse Rate (bpm) | 78.23 (8.63) | 76.96 (7.69) | 78.18 (8.10) | 0.426 ‡ |
IBS duration (months) | 20.81 (10.92) | 20.85 (12.29) | 22.07 (12.80) | 0.674 ‡ |
GAD score | 3.88 (1.81) | 4.04 (1.62) | 4.16 (1.64) | 0.378 § |
PHQ-9 score | 5.38 (3.15) | 5.61 (3.05) | 5.32 (2.96) | 0.749 ‡ |
Alcohol consumption | ||||
None, n (%) | 96 (88.1%) | 100 (90.1%) | 97 (88.2%) | |
Occasional, n (%) | 3 (2.8%) | 2 (1.8%) | 3 (2.7%) | 0.983 † |
Not available, n (%) | 10 (9.2%) | 9 (8.1%) | 10 (9.1%) |
Mean (SD) | p Value † | |||||
---|---|---|---|---|---|---|
Placebo (n = 109) | L. acidophilus DDS-1 (n = 111) | B. lactis UABla-12 (n = 110) | DDS-1 vs. Placebo | UABla-12 vs. Placebo | DDS-1 vs. UABla-12 | |
APS-NRS Score | ||||||
Day 0 | 6.94 (1.02) | 7.03 (0.99) | 6.84 (1.04) | 0.499 | 0.412 | 0.155 |
AbsΔ (Day 21) | −0.71 (0.92) | −1.24 (1.10) | −0.88 (0.99) | < 0.001 | 0.178 | 0.012 |
AbsΔ (Day 42) | −0.85 (1.45) | −2.59 (2.07) | −1.56 (1.83) | 0.001 | 0.001 | < 0.001 |
Mean (SD) | p Value † | |||||
---|---|---|---|---|---|---|
Placebo (n = 109) | L. acidophilus DDS-1 (n = 111) | B. lactis UABla-12 (n = 110) | DDS-1 vs. Placebo | UABla-12 vs. Placebo | DDS-1 vs. UABla-12 | |
IBS-SSS Total Score | ||||||
Day 0 | 298.07 (55.68) | 310.90 (52.47) | 305.45 (48.82) | 0.108 | 0.324 | 0.504 |
AbsΔ (Day 21) | −30.09 (57.76) | −56.06 (57.64) | −50.00 (63.72) | < 0.001 | 0.020 | 0.185 |
AbsΔ (Day 42) | −55.70 (86.42) | −133.4 (95.19) | −104.5 (96.08) | < 0.001 | < 0.001 | 0.039 |
Abdominal Pain Severity | ||||||
Day 0 | 66.74 (11.39) | 68.24 (11.73) | 65.82 (11.30) | 0.213 | 0.644 | 0.075 |
AbsΔ (Day 21) | −9.25 (15.09) | −15.50 (15.23) | −12.86 (16.36) | 0.001 | 0.077 | 0.121 |
AbsΔ (Day 42) | −13.41 (20.17) | −32.94 (21.78) | −24.52 (24.35) | < 0.001 | < 0.001 | 0.009 |
Abdominal Pain Duration | ||||||
Day 0 | 53.21 (15.69) | 59.73 (18.85) | 57.55 (17.57) | 0.016 | 0.139 | 0.344 |
AbsΔ (Day 21) | −4.77 (17.72) | −13.49 (21.79) | −10.95 (19.83) | 0.002 | 0.023 | 0.420 |
AbsΔ (Day 42) | −8.13 (19.53) | −28.44 (24.80) | −20.95 (23.19) | < 0.001 | < 0.001 | 0.018 |
Abdominal Distension | ||||||
Day 0 | 58.39 (17.81) | 60.14 (16.96) | 58.23 (17.79) | 0.428 | 0.822 | 0.247 |
AbsΔ (Day 21) | −7.66 (20.39) | −11.47 (16.26) | −9.67 (18.92) | 0.110 | 0.433 | 0.396 |
AbsΔ (Day 42) | −15.47 (23.81) | −27.20 (25.15) | −21.90 (25.85) | < 0.001 | 0.034 | 0.098 |
Bowel Habits | ||||||
Day 0 | 60.05 (14.38) | 63.06 (13.79) | 63.09 (12.06) | 0.122 | 0.119 | 0.974 |
AbsΔ (Day 21) | −4.11 (13.95) | −8.90 (13.82) | −8.86 (14.99) | 0.007 | 0.010 | 0.999 |
AbsΔ (Day 42) | −7.99 (23.46) | −22.89 (22.46) | −17.86 (22.06) | < 0.001 | 0.001 | 0.067 |
Effect on Quality of Life | ||||||
Day 0 | 59.68 (14.57) | 59.73 (13.70) | 60.77 (11.62) | 0.985 | 0.657 | 0.496 |
AbsΔ (Day 21) | −4.30 (15.76) | −6.70 (14.58) | −7.67 (15.61) | 0.043 | 0.112 | 0.663 |
AbsΔ (Day 42) | −10.70 (21.98) | −21.88 (22.27) | −19.29 (21.66) | < 0.001 | 0.001 | 0.316 |
Subjects (n, %) | ||||
---|---|---|---|---|
Group | Stool type (BSS) | Day 0 | Day 21 | Day 42 |
Placebo (n = 109) | Constipation (1–2) | 25 (22.9) | 19 (17.4) | 28 (25.7) |
Normal (3–5) | 70 (64.2) | 74 (67.9) | 68 (62.4) | |
Diarrhea (6–7) | 14 (12.8) | 14 (12.8) | 11 (10.1) | |
Data not available | 0 | 2 (1.8) | 2 (1.8) | |
L. acidophilus DDS-1 (n = 111) | Constipation (1–2) | 24 (21.6) | 14 (12.6) | 9 (8.1) |
Normal (3–5) | 63 (56.8) | 82 (73.9) | 93 (83.8) | |
Diarrhea (6–7) | 24 (21.6) | 13 (11.7) | 7 (6.3) | |
Data not available | 0 | 2 (1.8) | 2 (1.8) | |
B. lactis UABla-12 (n = 110) | Constipation (1–2) | 22 (20.0) | 18 (16.4) | 10 (9.1) |
Normal (3–5) | 67 (60.9) | 63 (57.3) | 83 (75.5) | |
Diarrhea (6–7) | 21 (19.1) | 24 (21.8) | 12 (10.9) | |
Data not available | 0 | 5 (4.5) | 5 (4.5) | |
p Value † | DDS-1 vs. Placebo | 0.234 | 0.733 | 0.002 |
UABla-12 vs. Placebo | 0.438 | 0.444 | 0.022 | |
DDS-1 vs. UABla-12 | 0.139 | 0.234 | 0.435 |
Subjects (n, %) | p (Within Group) † | ||||
---|---|---|---|---|---|
Group | Change in Stool Type | Day 0 to 21 | Day 0 to 42 | Day 0 to 21 | Day 0 to 42 |
Placebo (n = 107) | Non-normal to Normal | 21 (19.6) | 21 (19.6) | 0.511 | 1.000 |
Non-normal to Non-normal | 17 (15.9) | 17 (15.9) | |||
Normal to Non-Normal | 16 (15.0) | 22 (20.6) | |||
Normal to Normal | 53 (49.5) | 47 (43.9) | |||
L. acidophilus DDS-1 (n = 109) | Non-normal to Normal | 31 (28.4) | 38 (34.9) | 0.006 | < 0.001 |
Non-normal to Non-normal | 15 (13.8) | 8 (7.3) | |||
Normal to Non-Normal | 12 (11.0) | 8 (7.3) | |||
Normal to Normal | 51 (46.8) | 55 (50.5) | |||
B. lactis UABla-12 (n = 105) | Non-normal to Normal | 16 (15.2) | 28 (26.7) | 1.000 | 0.002 |
Non-normal to Non-normal | 26 (24.8) | 14 (13.3) | |||
Normal to Non-Normal | 16 (15.2) | 8 (7.6) | |||
Normal to Normal | 47 (44.8) | 55 (52.4) |
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Martoni, C.J.; Srivastava, S.; Leyer, G.J. Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial. Nutrients 2020, 12, 363. https://doi.org/10.3390/nu12020363
Martoni CJ, Srivastava S, Leyer GJ. Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial. Nutrients. 2020; 12(2):363. https://doi.org/10.3390/nu12020363
Chicago/Turabian StyleMartoni, Christopher J., Shalini Srivastava, and Gregory J. Leyer. 2020. "Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial" Nutrients 12, no. 2: 363. https://doi.org/10.3390/nu12020363
APA StyleMartoni, C. J., Srivastava, S., & Leyer, G. J. (2020). Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial. Nutrients, 12(2), 363. https://doi.org/10.3390/nu12020363