PMID- 30264164
OWN - NLM
STAT- MEDLINE
DCOM- 20190403
LR  - 20200225
IS  - 1432-1041 (Electronic)
IS  - 0031-6970 (Linking)
VI  - 75
IP  - 1
DP  - 2019 Jan
TI  - A prospective, interventional, randomized, double-blind, placebo-controlled 
      clinical study to evaluate the efficacy and safety of Bacillus coagulans LBSC in 
      the treatment of acute diarrhea with abdominal discomfort.
PG  - 21-31
LID - 10.1007/s00228-018-2562-x [doi]
AB  - PURPOSE: Increasing resistance towards antibiotics has augmented the use of 
      probiotics for the treatment of diarrhea and associated symptoms. Probiotics are 
      active microorganisms which exert some health benefits when consumed in the right 
      amount. This randomized, double-blind, placebo-controlled clinical trial was 
      conducted on 60 "intention to treat" subjects to evaluate the safety and efficacy 
      of probiotic preparation Lactic Acid Bacillus (LAB containing active ingredient 
      Bacillus coagulans strain LBSC) for the treatment of acute diarrhea with 
      abdominal discomfort. METHODS: The Test-A arm (n = 30) was on B. coagulans LBSC 
      [2 billion/g] and Placebo-B arm (n = 30) was on the carrier. The primary outcomes 
      were the time to last unformed stool (TTLUS), number of unformed stools, change 
      in severity of abdominal pain, time to complete resolution of abdominal 
      discomfort, complete remission of diarrhea, and quality of life (QoL). The 
      secondary outcomes were physical examination and vitals, hematological analysis, 
      and assessment of reported adverse events (AEs) or serious adverse events (SAEs). 
      RESULTS: Trial data showed that the LAB was well-tolerated by participants at the 
      dose provided. The LAB was effective in recovering from acute diarrhea with 
      abdominal pain and discomforts and exhibited improved cluster of QoL. No AEs or 
      SAEs were reported during the trial. CONCLUSIONS: It is evident that the test 
      drug, i.e., LAB (B. coagulans strain LBSC) is safe and effective for improving 
      the pathophysiological conditions related to acute diarrhea and abdominal 
      discomfort evaluated through stage-II clinical trial.
FAU - Maity, Chiranjit
AU  - Maity C
AUID- ORCID: 0000-0001-9400-3947
AD  - Probiotics Laboratory, Advanced Enzyme Technologies Ltd., 5th Floor, A-Wing, Sun 
      Magnetica, LIC Service Road, Louiswadi, Thane (W), Maharashtra, 400 604, India. 
      chiranjit@advancedenzymes.com.
FAU - Gupta, Anil Kumar
AU  - Gupta AK
AD  - Probiotics Laboratory, Advanced Enzyme Technologies Ltd., 5th Floor, A-Wing, Sun 
      Magnetica, LIC Service Road, Louiswadi, Thane (W), Maharashtra, 400 604, India.
LA  - eng
GR  - NTRC/WO No. 2142601/Advanced Enzyme Technologies Ltd./
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20180928
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
SB  - IM
MH  - Abdominal Pain/etiology/*therapy
MH  - Adolescent
MH  - Adult
MH  - *Bacillus coagulans
MH  - Diarrhea/*therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Probiotics/*administration & dosage/adverse effects
MH  - Prospective Studies
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Abdominal pain
OT  - Bacillus coagulans
OT  - Bristol stool scale
OT  - Diarrhea
OT  - Quality of life
EDAT- 2018/09/29 06:00
MHDA- 2019/04/04 06:00
CRDT- 2018/09/29 06:00
PHST- 2018/08/18 00:00 [received]
PHST- 2018/09/21 00:00 [accepted]
PHST- 2018/09/29 06:00 [pubmed]
PHST- 2019/04/04 06:00 [medline]
PHST- 2018/09/29 06:00 [entrez]
AID - 10.1007/s00228-018-2562-x [pii]
AID - 10.1007/s00228-018-2562-x [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2019 Jan;75(1):21-31. doi: 10.1007/s00228-018-2562-x. Epub 
      2018 Sep 28.