Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02765217 |
| Other study ID # |
PROBAGE006 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Recent studies showed that intestinal microbiota consist more than thousand bacteria, and
these microorganisms play the role as balance and continuity of the anatomical and functional
integrity gastrointestinal tract. Chronic diseases, nutritional factors, lifestyle factors
and medications including antibiotics changes the host microbiota in short or long-term
period. Antibiotics are the most commonly used drugs in pediatrics routine practice. Although
frequency and severity of side effects alter the choice of drug, mild complications may be
taken into consideration for treatment by a physician in the profit and loss balance. Our
study group (PROBAGE Working Group) have been recently showed that Lactobacillus reuteri DSM
17938 reduced the duration of diarrhea in children with acute infectious diarrhea, and are
safe and well-tolerated. In this study the investigators aim to evaluate the potential effect
of Lactobacillus reuteri DSM 17938 on the prevention of antibiotic associated diarrhea in
children.
Description:
Recent studies showed that intestinal microbiota consist more than thousand bacteria, and
these microorganisms play the role as balance and continuity of the anatomical and functional
integrity gastrointestinal tract. Chronic diseases, nutritional factors, lifestyle factors
and medications including antibiotics changes the host microbiota in short or long-term
period. Antibiotics are the most commonly used drugs in pediatrics routine practice. Although
frequency and severity of side effects alter the choice of drug, mild complications may be
taken into consideration for treatment by a physician in the profit and loss balance.
Antibiotic-associated diarrhea is one of the side effects that occur during antibiotic use,
the frequency varies according to region and antibiotic type. Aminopenicillins,
cephalosporins and clindamycin antibiotics has been identified as the most affected group of
antibiotic-associated diarrhea. Development of antibiotic associated diarrhea are associated
with the intestinal microbiota balance , the mucosal integrity and changes of vitamin /
mineral metabolism 3. Majority cases with antibiotic associated diarrhea admit with the
complaints of abdominal crampy pain and diarrhea while pseudomembranous enterocolitis, in
severe cases, even death have been reported. Antibiotic-associated diarrhea can be occur
during antibiotic treatment but may seen at 2-3 weeks later after termination of treatment.
Broad-spectrum antimicrobial agents have been related 11-40% of antibiotic associated
diarrhea cases in children.
In Turkey there are no large studies on the frequency of antibiotic associated diarrhea in
children, but antibiotics are the most commonly used drug classes in childhood. The use of
broad-spectrum antibiotics, which creates more risk than narrow-spectrum antibiotics, and the
highest risk have been observed during use of clindamycin, cephalosporins and
fluoroquinolones. However, there is no consensus about which antibiotics which are high risk
or which have significant negative impact on the microbiota. Antibiotic-associated diarrhea,
has been shown to increase the growth of enteropathogens after antibiotic use.
In particular, Clostridium difficile (C. difficile) infections are the most common infections
which related with antibiotic associated diarrhea 2. Although C. difficile diarrhea mostly
occurs in adults and hospitalized immunocompromised patients, it can be seen in children.
C. difficile leads to mild diarrhea to pseudomembranous colitis according to toxins. C.
difficile associated 10-20% of all antibiotic-associated diarrhea forms and can be seen until
after eight weeks of treatment with antibiotics. Antibiotics disrupt the integrity of the
normal colonic mucosa, affect carbohydrate metabolism as a result of antimicrobial activity
in the colon leads to the development of osmotic diarrhea and pathogenic bacteria associated
diarrhea. The slowing of the metabolism of carbohydrates results in the reduction of
short-chain fatty acids in the intestinal lumen and cause accumulation of carbohydrates which
can not be absorbed. Besides the harm normal microbiota have provided the protective barrier
and intestinal system becomes sensitive to resistant microorganisms. Reduction of intestinal
lumen and in the number of Bacteroides and Bifidobacteria strains of facultative anaerobes
(Fusobacterium the Clostridia, Eubacteria) results in the increase. Antibiotic-associated
diarrhea, alongside a negative effect on the quality of life of the host, the cost of
treatment in patients hospitalized in the hospital and also negatively affects the length of
stay.
In case of outpatient treatment, or in hospitalized patients, antibiotic treatment usually is
terminated or is changed, it affects the success of the treatment in this case and leads to a
longer stay in hospital. Especially the long-term hospitalization in the intensive care unit
at the hospital caused by an increase in the risk of nosocomial infections and has been shown
to cause mortality 14.
In case of diarrhea in patients treated ambulatory during treatment if the patient's symptoms
also declined, antibiotic treatment is interrupted by family. If cases can result in use
therefore again brought to the physician if the physician broader spectrum antibiotics or
parenteral drugs.
In studies with probiotics, some of the probiotic strains of antibiotic-associated diarrhea
development when used in combination with antibiotics it has been shown to be significantly
reduced. Harvard / Yale probiotic Workshop Group, World Gastroenterology Organization in the
prevention of antibiotic associated diarrhea probiotic strains showed that the level of
evidence A1. However, probiotics effects are strain specific. Although Saccharomyces
boulardii and Lactobacillus GG are well known strains for prevention of antibiotic associated
diarrhea, knowledge about the Lactobacillus reuteri DSM 17938 is limited.
Our study group (PROBAGE Working Group) have been recently showed that Lactobacillus reuteri
DSM 17938 reduced the duration of diarrhea in children with acute infectious diarrhea, and
are safe and well-tolerated. In this study the investigators aim to evaluate the potential
effect of Lactobacillus reuteri DSM 17938 on the prevention of antibiotic associated diarrhea
in children.
