Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial
Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated <i>...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-10-01
|
| Series: | Nutrients |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2072-6643/15/21/4490 |
| _version_ | 1797631468378259456 |
|---|---|
| author | Craig Patch Alan J. Pearce Mek Cheng Ray Boyapati J. Thomas Brenna |
| author_facet | Craig Patch Alan J. Pearce Mek Cheng Ray Boyapati J. Thomas Brenna |
| author_sort | Craig Patch |
| collection | DOAJ |
| description | Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated <i>Bacillus subtilis</i> (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID. Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention. Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (<i>p</i> = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, <i>p</i> < 0.001), indigestion (11% improvement, <i>p</i> = 0.04), and dyspepsia (10% improvement, <i>p</i> = 0.04) were significantly improved in the intervention group compared to the placebo. Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted. Trial registration: This study was registered prospectively (25 October 2021) at the Australian New Zealand Clinical Trials Registry (ACTRN12621001441808p). |
| first_indexed | 2024-03-11T11:23:58Z |
| format | Article |
| id | doaj.art-08659a8f15f9471c9c2aff50d69ecc18 |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-11T11:23:58Z |
| publishDate | 2023-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-08659a8f15f9471c9c2aff50d69ecc182023-11-10T15:09:22ZengMDPI AGNutrients2072-66432023-10-011521449010.3390/nu15214490Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled TrialCraig Patch0Alan J. Pearce1Mek Cheng2Ray Boyapati3J. Thomas Brenna4School Allied Health, Human Services and Sport, Melbourne 3086, AustraliaSchool Allied Health, Human Services and Sport, Melbourne 3086, AustraliaAdepa Lifesciences, Melbourne 3000, AustraliaDepartment of Gastroenterology, Monash Health, Melbourne 3977, AustraliaAdepa Lifesciences, Melbourne 3000, AustraliaBackground: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated <i>Bacillus subtilis</i> (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID. Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention. Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (<i>p</i> = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, <i>p</i> < 0.001), indigestion (11% improvement, <i>p</i> = 0.04), and dyspepsia (10% improvement, <i>p</i> = 0.04) were significantly improved in the intervention group compared to the placebo. Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted. Trial registration: This study was registered prospectively (25 October 2021) at the Australian New Zealand Clinical Trials Registry (ACTRN12621001441808p).https://www.mdpi.com/2072-6643/15/21/4490probiotics<i>Bacillus subtilis</i>functional gastrointestinal disordersGastrointestinal Symptom Rating Scale |
| spellingShingle | Craig Patch Alan J. Pearce Mek Cheng Ray Boyapati J. Thomas Brenna Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial Nutrients probiotics <i>Bacillus subtilis</i> functional gastrointestinal disorders Gastrointestinal Symptom Rating Scale |
| title | Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial |
| title_full | Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial |
| title_fullStr | Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial |
| title_full_unstemmed | Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial |
| title_short | Bacillus Subtilis (BG01-4<sup>TM</sup>) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial |
| title_sort | bacillus subtilis bg01 4 sup tm sup improves self reported symptoms for constipation indigestion and dyspepsia a phase 1 2a randomized controlled trial |
| topic | probiotics <i>Bacillus subtilis</i> functional gastrointestinal disorders Gastrointestinal Symptom Rating Scale |
| url | https://www.mdpi.com/2072-6643/15/21/4490 |
| work_keys_str_mv | AT craigpatch bacillussubtilisbg014suptmsupimprovesselfreportedsymptomsforconstipationindigestionanddyspepsiaaphase12arandomizedcontrolledtrial AT alanjpearce bacillussubtilisbg014suptmsupimprovesselfreportedsymptomsforconstipationindigestionanddyspepsiaaphase12arandomizedcontrolledtrial AT mekcheng bacillussubtilisbg014suptmsupimprovesselfreportedsymptomsforconstipationindigestionanddyspepsiaaphase12arandomizedcontrolledtrial AT rayboyapati bacillussubtilisbg014suptmsupimprovesselfreportedsymptomsforconstipationindigestionanddyspepsiaaphase12arandomizedcontrolledtrial AT jthomasbrenna bacillussubtilisbg014suptmsupimprovesselfreportedsymptomsforconstipationindigestionanddyspepsiaaphase12arandomizedcontrolledtrial |