Evaluation of Bacillus Subtilis R0179 on General Wellness, Gastrointestinal Symptoms and Gastrointestinal Viability

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Material Information

Title:
Evaluation of Bacillus Subtilis R0179 on General Wellness, Gastrointestinal Symptoms and Gastrointestinal Viability a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial in Healthy Adults
Physical Description:
1 online resource (126 p.)
Language:
english
Creator:
Hanifi, Abdulah
Publisher:
University of Florida
Place of Publication:
Gainesville, Fla.
Publication Date:

Thesis/Dissertation Information

Degree:
Master's ( M.S.)
Degree Grantor:
University of Florida
Degree Disciplines:
Food Science and Human Nutrition
Committee Chair:
DAHL,WENDY JOANNE
Committee Co-Chair:
HENKEN,ROBIN J
Committee Members:
MAI,VOLKER

Subjects

Subjects / Keywords:
bacillus -- gastrointestinal -- probiotics -- subtilis -- wellbeing
Food Science and Human Nutrition -- Dissertations, Academic -- UF
Genre:
Food Science and Human Nutrition thesis, M.S.
bibliography   ( marcgt )
theses   ( marcgt )
government publication (state, provincial, terriorial, dependent)   ( marcgt )
born-digital   ( sobekcm )
Electronic Thesis or Dissertation

Notes

Abstract:
Bacillus subtilis R0179 has been marketed in Asia as the probiotic Medilac®. This probiotic formulation is composed of Enterococcus faecium R0026 and Bacillus subtilis R0179 in a 9:1 ratio. However, prior research has not evaluated B. subtilis R0179 as a single probiotic agent at doses higher than 0.1 billion CFU/capsule. To confirm the oral dose-response tolerance of B. subtilis R0179, a 6-week randomized, double-blind, placebo-controlled clinical trial in healthy adults (n=81), 18-50 years of age, was conducted. Methods: Participants were randomized to one of three B. subtilis R0179 dosages (0.1, 1 and 10 billion cfu/capsule/day) or placebo for a 4-week intervention period. General wellness was evaluated using a daily questionnaire (DQ) composed of six syndromes rated on a scale of 0 (none) to 6 (very severe): gastrointestinal distress, cephalic, ear-nose-throat, behavioral, emetic, and epidermal. Gastrointestinal symptoms were evaluated pre-intervention, during intervention and post intervention with the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS contains five syndromes rated on a scale of 1 (no discomfort) to 7 (very severe discomfort): abdominal pain, indigestion, reflux, constipation and diarrhea. Three stool samples were obtained, at pre-intervention, intervention and post intervention time points to assess the viability of B. subtilis in the human gastrointestinal tract. Symptom data were analyzed using the equivalence testing method to assess dose response by week. Kruskall-Wallis tests were used to compare pre-intervention and intervention syndrome scores for both the GSRS and DQ. Gastrointestinal viability was compared on a per week by treatment basis using ANOVA and Tukey-Kramer HSD when appropriate. Results: General wellness and gastrointestinal function was not adversely affected by oral consumption of B. subtilis R0179 at any dose. Mean intervention DQ syndromes were not different from baseline and ranged from 0.04 to 0.7. Mean intervention GSRS syndromes were not different from baseline and ranged from 1.1 to 1.9. Fecal viable counts of B. subtilis R0179 demonstrated a dose response ranging from 101 to 105 CFU/g. No side effects of any kind were reported. Conclusions: Overall, the results demonstrate that consumption of B. subtilis R0179 was well tolerated by healthy human adults and is viable in the human gastrointestinal tract.
General Note:
In the series University of Florida Digital Collections.
General Note:
Includes vita.
Bibliography:
Includes bibliographical references.
Source of Description:
Description based on online resource; title from PDF title page.
Source of Description:
This bibliographic record is available under the Creative Commons CC0 public domain dedication. The University of Florida Libraries, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.
Statement of Responsibility:
by Abdulah Hanifi.
Thesis:
Thesis (M.S.)--University of Florida, 2013.
Local:
Adviser: DAHL,WENDY JOANNE.
Local:
Co-adviser: HENKEN,ROBIN J.
Electronic Access:
RESTRICTED TO UF STUDENTS, STAFF, FACULTY, AND ON-CAMPUS USE UNTIL 2015-12-31

Record Information

Source Institution:
UFRGP
Rights Management:
Applicable rights reserved.
Classification:
lcc - LD1780 2013
System ID:
UFE0046049:00001