Title No. of subject, Age and Age Group (grp) Duration of Study and dosage Symptoms Parameters studied Results
Efficacy of Bacillus clausii strain UBBC-07 in the treatment of patients suffering from acute diarrhea. Sudha MR, Bhonagiri S, Asin MK (2013) Beneficial Microbes 4: 211-216. 27outpatients 15malesand12females Grp: 35.44±8.0 10 days
One capsule of B. clausii
strain UBBC-07 (containing
2 × 109 cfu) two times a day
for a period of 10 days.
≥ 3 loose stool
motions within
24 hours and for
more than 7 days.
Duration of diarrhoea, frequency of defecation, abdominal pain and stool consistency were tested on days 1, 3, 6 and 10. Allpatients reportedasignificantimprovementinduration ofdiarrhoea, frequencyofdefecationand stoolconsistency by the end of the study.
Bacillus clausii therapy to reduce side-effects of anti-Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial
Nista et al (2004) Aliment PharmacolTher 20: 1181–1188.
Treatment group-Sixty Outpatients (male/female 33/27)
Grp: 46.2 ±12.83 Placebo- Sixty Outpatient (male/female 25/35.
Grp: 43.1 ±13.36
Treatment group- A triple
therapy based on clarithromycin 500 mg b.d.,amoxicillin 1 g b.d., rabeprazole 20 mg b.d. for
7 days plus a probiotic preparation, one vial t.d.s. (each vial containing 2 x109 spores of B. clausii,for 14 days, during eradication therapy and 1 week thereafter Placebo- same treatment without Bacillus clausii in thevial
Affected by gastric H. pylori infection as confirmedby a13C-urea breath test. -Helicobacter pylori eradication was evaluated by meansof a13C-urea breath 6 weeks after the end of thetreatment. -Validated dailydiary for 4 weeks, starting from the first day of the eradicating treatment.
The diary contains a questionnaire evaluatingonset, intensity and frequency of gastrointestinal side-effects: taste distortion, loss of appetite, nausea, vomiting, epigastric pain, bloating, diarrhoea,constipationand skin rash. The intensity of symptoms was ratedusing a scale.
There was a significant difference between the B.clausii treated group and placebo in theincidence of nausea, diarrhoea and epigastric pain. A greater reduction in the risk of diarrhoea was observed in theB. clausiigroup compared with the placebo groupafter one and 2 weeks. The mean intensities and frequencies of nausea anddiarrhoea were also significantly lower in the B. clausiigroup
Effectiveness of Bacillus clausii in reducing duration of illness in acute diarrhoea in children 6-59 months of age admitted with severe dehydration Maugo BM (2012) Diss. University of Nairobi, Kenya, 2012. Hospitalized patients:
Treatment group-90 Placebo group-46 Grp: 6 months to 5 years
B.clausii at 2x109CFUs/5ml vial or placebo, twice daily, for 5 days. Acute diarrhoea and WHO criteria of severe dehydration Duration of diarrhoea -Frequency of diarrhoea -Hospital stay In children admitted with acute diarrhea and severe dehydration, no significant difference in reducing the duration of diarrhoea and duration of hospital stay in the two groups. However significant decrease in the number of stools was seen on day 3 and 4 of treatment
Efficacy and Safety of Bacillus clausii in Preventing Antibiotic-associated Diarrhea among Filipino Infants and Children: A Multi-center, Randomized, Open-label Clinical Trial
R.V Destura ( 2013)
http://en.sanofi.com/img/content/study
/ENTER_L_01125_summary.pdf
Outpatients: Treatment group=162 Placebo-61 Grp: 6 months to 12 years Treatment group received a twice daily dose of 1 vial of 2x109 of B. clausiispores per orem within 24 hours of antibiotic initiation and were continued until the last day of antibiotic therapy( duration of antibiotic treatment~ 8 days). Children on antibiotics for mild to moderate infection of the respiratory, genitourinary or skin and soft tissue. Occurrence of Diarrhoea In the B. clausii treated group, lower incidence of diarrhoea.
Bacillus clausiiAs An Adjuvant Therapy In Acute Childhood Diarrhoea. Keya L et al. (2015) IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) p-ISSN: 2279-0861.Volume 14, Issue 5 Ver. I, PP 74-76 131 Hospitalized children: 83 males, 48 females
Gp1-69
Gp2-62 Grp: 6 months to 12 years
Two groups-Group 1 comprised of children who were administered oral rehydration therapy (ORT) with Zinc and Bacillus clausiiand Group 2 was treated with ORT and Zinc Children were administered one mini bottle containing 2 billion spores of Bacillus clausii12 hourly for 5 days. They were followed up at 6 hours, 12 hours, 24, 36, 48, 60 and 72 hours. Acute Diarrhoea -Duration of diarrhoea
-Frequency of diarrhoea
-Hospital stay
-Direct and indirect costs
It significantly reduced the duration and frequency of diarrhoea. In addition, it lowered the hospital stay thereby downscaling the financial burden
Table 1: Summary of clinical studies on effect of Bacillus clausii treatment on diarrhoea.