Probiotic Use in Ulcerative Colitis
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In Patients Diagnosed Inflammatory Bowel Disease, Does the Use of Probiotics Help to
Induce Remission and Maintain Bowel Health?
Sarah Buckley
University of New Hampshire
Probiotic Use in Ulcerative Colitis
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Background and Rationale
Ulcerative Colitis is an inflammatory bowel disease manifested by inflammation of the
lining of the large intestine, specifically the colon and rectum. The cause of this disease is a
combination of genetics, environmental factors, and a patient’s unique immune system that can
trigger the disease. This damaging inflammation irritates and damages the mucosal lining of the
large intestine which causes rectal bleeding, diarrhea, painful abdominal cramping, stool
urgency, and tenesmus, a feeling of discomfort that you have not completely emptied your
rectum after a bowel movement. In severe ulcerative colitis, patients develop fevers,
dehydration, severe abdominal pain, weight loss, and anorexia. For most patients, ulcerative
colitis tends to follow a course marked by periods of disease activity followed by periods during
which the patient is symptom free. In patients diagnosed with ulcerative colitis, the medical
treatment generally focuses on induction of remission and the maintenance of that remission
which is done by controlling these symptoms and reducing the inflammation and irritation.
Achieving and maintain remission is so important to prevent further damage that could lead to
frequent flare ups, megacolon, colon cancer, ostomies, and surgeries(Lynch & Bloomfield,
2014).
However, achieving remission can be a challenge. There are four main groups of
medication treatment: aminosalicylates, steroids, immunomodulators, and biologics.
Traditionally, aminosalicylates are prescribed for patients with mild to moderate colitis and
typical have no adverse effects. Steroids, immunomodulators, and biologics are prescribed for
patients who suffer from moderate to severe colitis however each of these medications come
with a variety of adverse effects such as osteoporosis, low white blood cell counts, and infusion
reactions. Although these medications are prescribed for a reason, sometimes patients do not find
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relief in taking these medications. Typically, depending on the severity, a patient will either start
on aminosalicylates or steroids and then move onto to immunomodulators and biologics as a
patient’s flare ups become more severe and debilitating. Ulcerative colitis is already a difficult
disease to live with that affects a patient’s quality of life, adding medications that have adverse
effects to it does not make it any easier for this patient population (Lynch and Bloomfield,2014).
It is important to always stay curious and never stop looking for alternative therapies to help
induce and maintain remission such as probiotic use. Probiotics are bacteria similar to the
beneficial bacteria found naturally in the human gut. According to the U.S. Department of
Health& Human Services, probiotics may account for altering intestinal “microecology”
reducing harmful organisms that may irritate the intestine (Hibberd, 2012). Therefore, this is a
valuable research question that could potentially improve patient outcome. Researching the
usage of probiotics in treatment of ulcerative colitis is important because a nurse is a patient
advocate and if the nurse is knowledgeable about alternative therapies that nurse can work with a
patient’s prescriber to look for different strategies to help a patient achieve remission without
constantly reverting to steroids (Lynch & Bloomfield, 2014).
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Search Methods
In order to find the necessary information to make a decision as to whether or not
probiotics help induce remission and maintain bowel health in patients diagnosed with ulcerative
colitis I utilized the CINAHL and MEDLINE databases that are available through the UNH
library. Before I explored these databases I used the search engine, Google Scholar, to
familiarize myself with the pathophysiology and typical treatment regimen of ulcerative colitis.
Google Scholar connected me to websites such as the CDC, the American College of
Gastroenterology, and the Crohn’s and Colitis Foundation of America that provided me with
information regarding the pathophysiology, treatment, and complications of ulcerative colitis.
This method of research aided me in creating key words that I could later use to conduct research
in the databases. The key words that I used included: ulcerative colitis, IBD, probiotics,
inflammation, remission, systematic review, and/or meta-analysis. While researching, the limits I
used were English only, human research only, adolescent (13-18), adulated, middle aged, and
aged as age groups to research; I am only interested in these age groups because ulcerative colitis
is usually diagnosed in young adulthood (Hibberd, 2014). I identified three sources that I used to
answer my question. While picking adequate citations to include in my research, my inclusion
criteria incorporated adolescent and adult patients, excluding research done on pediatric patients
because it is not common in that age group. I used articles and journals that were published in
2007 and after and excluded any research done prior to that because I want to use up to date
research in order to present the most recent research to patients who are suffering with ulcerative
colitis. Pilot studies and not randomized controlled trails were excluded because of a lack of
credibility. Systematic reviews and meta-analysis of randomized or quasi-randomized trials were
included due to their strong credibility and inclusion of many studies.
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Critical Appraisal of the Evidence
In my first study, Remission Induction and Maintenance Effect of Probiotics
on Ulcerative Colitis: A Meta-analysis, the authors searched electronic databases such as
MEDLINE, EMBASE, and the Cochrane Controlled Trials Register selecting 13 randomized
controlled studies out of 286 papers that were first retrieved from these databases. Two
researchers selected the papers after reviewing the titles, abstracts, and full texts excluding
reviews, uncontrolled tests and basic research. Selection criteria included: adult and pediatric
studies, the experiments compared the curative effect of probiotics with standard therapy for
ulcerative colitis or placebo, all were random control tests, abstracts and presentations were
selected, and the patients in each article had a definite diagnosis of ulcerative colitis. If these two
researchers had different opinions about which papers should be included, a third researcher
helped them to determine if the paper was applicable to their meta-analysis. The researchers
assessed quality by using the Cochrane reviewer Handbook 5.0 random control experiment
quality assessment standard which evaluates and assesses the random method, allocation
concealment, the blind method, and whether there are lost or exit conditions. In assessing each
category if all of the categories were satisfied then the possibility of bias is small and the study
was labeled as a level “A”. If one or more of the criteria was not described, meaning the
assessment was partially satisfied and that there is a possibility of relative bias; this study would
be labeled as a level “B”. Finally, if one or more categories were erroneous or not used, there
was a high possibility of relative bias and the study would be considered to be a level “C”. Out
of the 13 chosen papers, 3 studies were level A, eight were level B, and two papers were level C.
This process of quality assessment of each paper is a strength of this meta-analysis. Both
researchers carefully read each paper before deciding to include it into their paper and utilized a
Probiotic Use in Ulcerative Colitis
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strict evaluation system to assess bias, the Cochrane reviewer Handbook 5.0 random control
experiment quality assessment standard that was established by a reputable enterprise. Although
the researchers thoroughly assessed each paper, a weakness of this meta-analysis is the inclusion
of two level C papers that have a high possibility of bias. Furthermore, another strength of this
meta-analysis is the quality and analysis process that used two reviewers who worked
independently and them came together to reach a consensus; a third party was consulted when
there was disagreement. In my opinion, the strengths of this meta-analysis provide me with the
power to rely on the numerous papers referenced to justify its results as being useful and
relevant. This study shows that using probiotics provides no additional benefits in inducing
remission of ulcerative colitis but it does show that probiotic auxiliary therapy to medications is
better than non-probiotics therapy for maintenance (Sang et al., 2010).
In the second review Intervention Review I used titled Probiotics for Induction of
Remission in Ulcerative Colitis; the authors searched completed a comprehensive search for
relevant randomized controlled trials using MEDLINE, EMBASE, CENATRAL, and the
Cochrane IBD/FBD Review Group Specialized Trails Registrar. Additionally the authors handsearched conference proceeding from the Falk Symposium, Digestive Disease Week, and the
United European Digestive Disease week in search of relevant studies and information. Two
authors assessed the eligibility of each trial for inclusion in the study using the following
selection criteria: sample characteristics such as age, size, proven ulcerative colitis, disease
extent, and severity, probiotics for at least one treatment arm, randomised or quasi-randomised
treatment allocation, and symptom score as at least one measure of outcome. Any disagreement
between the two authors about trial inclusion was solved by discussion and further assessment.
Once 4 specific trails were selected, a quality assessment was performed independently by the
Probiotic Use in Ulcerative Colitis
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two authors considering aspects of radomisation, allocation concealment, withdrawal and
dropout rate, whether data were analyzed on an intent-to-treat basis, and whether the participants
and the outcome assessors were blind to the treatment provided. Once all the trails were chosen
for inclusion, data were analyzed using the ReVMan Analyses that is produced by the Cochrane
Informatics and Knowledge Management Department; therefore, we know that the data collected
is reputable. Furthermore, 119 references were reviewed and the two authors chose four
randomised controlled trials that satisfied the inclusion criteria. A strength of this review is that
the authors performed an extensive search to identify trials that could be used in their review.
The authors used respected search engines and were specific when picking trails to include: out
of 119 trails they reviewed only four were included. Additionally, both authors usage of the
ReVMan software to analyze the data is a strength of the review because that software is
produced by a reputable and trusted enterprise. However, when researched on the Cochrane
Review website, the ReVMan software is not given a specific description about its way of
analyzing data which leaves the readers with unanswered questions about how it was exactly
analyzed. Furthermore, weaknesses also include the possibility of bias because two out of the
four trials included did not indicate the technique used for randomization and when the authors
were contacted for clarification, they did not respond. Allocation concealment was adequate in
one out of the four trials while in three out of the four trails allocation concealment was unclear.
These two concepts suggest that there is a risk for bias in this review. But it should be noted that
another strength of this review is that it was published in The Cochrane Library which suggests
that its findings are significant. In the end, the results of this review state that none of the
included studies reported any statistically significant differences in remission or clinical
Probiotic Use in Ulcerative Colitis
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improvement rates between probiotic and placebo or active comparator groups in patients
diagnosed with ulcerative colitis(Sang et al., 2010).
In the third journal article titled Probiotics for Maintenance of Remission in Ulcerative
Colitis the authors performed a literature search of publications using CENTRAL, MEDLINE,
EMBASE, CINAHL, and the Cochrane Inflammatory Bowel Disease and Functional Bowel
Disorder Group Specialised Trial Register. The selection criteria for this academic journal
included randomised controlled trials that compared probiotics against placebo or any other
intervention for the maintenance of ulcerative colitis were eligible for inclusion. Additional
selection criteria included consideration of patient characteristics such as age, size of trial
population, ulcerative colitis diagnosis, disease extent, and severity. Data extraction and quality
assessment of the included studies were independently performed by two authors. Any
disagreements between the two authors were discussed and a third researcher helped them to
determine if the paper was applicable to their review. Four studies were included in the review.
Three trails compared probiotics to mesalazine (typical treatment for ulcerative colitis) and one
trial compared probiotics with a placebo pill. These four studies were assessed for quality by the
authors. The risk of bias was high in two out of the four studies because of reported incomplete
outcome data and lack of blinding which is a weakness in the review. Additionally, in the four
studies allocation concealment methods were unclear. Although only four trials were included in
the review, each trial was hand-picked and analyzed thoroughly. Another strength of this review
was the extensive literature review from many credible databases. It is also worth noting that this
review is published in the Cochrane Database of Systematic Reviews which is highly regarded as
the highest standard in evidence-based health care. Although this review does have some
weaknesses, the Cochrane Database recognized it as being worthy of publication meaning it adds
Probiotic Use in Ulcerative Colitis
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some value to the medical and nursing field (Cochrane Reviews, 2014). In Conclusion, based on
this review there was no statistically significant difference between the use of probiotics and the
traditional colitis medication, mesalazine, for maintenance of remission in ulcerative colitis.
Relapse was reported in 40.1% of patients in the probiotics group compared to 34.1% of patients
in the mesalazine group. As well as 75% of probiotic patients relapsed at one year compared to
92% of placebo patients (Naidoo, 2011). .
Probiotic Use in Ulcerative Colitis
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Evidence Synthesis
The evidence gathered from all the previous three analyses and reviews, as a body of
evidence, suggests that taking probiotics does not induce remission and maintain bowel health. .
In the first meta-analysis performed by Sang, Chang, Zhang, Wu, Li, and Jiang, it examined 13
RCTs that evaluated the induction of remission and maintenance effects of probiotics for
ulcerative colitis, which showed that using probiotics provides no additional benefits in inducing
remission of ulcerative colitis but it does show that probiotic auxiliary therapy to medications is
better than non-probiotics therapy for maintenance. Although this meta-analysis included two
RCTs that were labeled level C with a high possibility of bias, that is only two out of thirteen
RCTs included in the meta-analysis. Furthermore, the authors of this meta-analysis performed a
thorough quality assessment of each RCT by using the Cochrane reviewer Handbook 5.0 random
control experiment quality assessment standard. Given this information, the results of this metaanalysis are somewhat significant to nursing practice and this research should be taken into
consideration when discussing probiotic use in patients diagnosed with ulcerative colitis. Mallon,
McKay, Kirk, and Gardiner’s review of probiotic use in ulcerative colitis included four RCTs
that the authors thoroughly assessed and hand-picked based on very specific selection criteria.
Once these RCTs were chosen they were analyzed using the ReVMan Analyses that is produced
by the Cochrane Informatics and Knowledge Management Department meaning it is trustworthy.
However a possibility of bias was identified in the included RCTs suggesting that the
information required to definitively address these questions are incomplete and further research
is needed. Although this bias is important to note, this review has many strengths that should be
noted as well such as an extensive database literature search, the usage of the ReVMan tool to
analyze the data. Lastly it is important to note that this review was published in The Cochrane
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Library, an internationally known as the highest standard in evidence-based health care, meaning
the review is significant to the medical world because if it was not, then it would not have been
published. The results from the individual trials are interesting and should be taken into
consideration to some account. To continue, Naidoo’s review of probiotic use in ulcerative
colitis included four RCTs that revealed there were no statistical significances between the use of
probiotics and the traditional colitis, suggesting that probiotics do not induce and maintain
remission in patients with ulcerative colitis. Like the other review, the risk of bias was high in
two out of the four studies because of reported incomplete outcome data, lack of blinding, and
unclear allocation concealment methods. Although these are weaknesses this review this review
has some significance as it was also published by the Cochrane Database of Systematic Reviews.
As a whole, in regards to all three literature reviews, the data collected suggests that the use of
probiotics in patients diagnosed with ulcerative colitis does not help induce remission and
maintain bowel health. As nurses we can inform our patients that at this point research does not
show that probiotics can help with symptoms but to encourage our patients to keep trying other
alternative therapies to reinforce medications and participate in future research about probiotics.
Although each review had its weak points, the reviews taught us that further clinical trials are
needed whether the use of probiotics are better than non-probiotic therapy to induce and maintain
remission, including variations of bacterial species, applied dosage, treatment timing, and the
course of treatment. These results present valid beginning points that can spur more research into
different variations of probiotics and how they can better help the colons of those suffering from
ulcerative colitis. In conclusion, at this point in time taking probiotics does not help to induce
remission and maintain bowel health.
Probiotic Use in Ulcerative Colitis
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Clinical and Research Recommendations
Based on the results of my research, there is no evidence to suggest that probiotics help to
induce remission and maintain bowel health once remission is achieved. Therefore, when caring
for patient with ulcerative colitis a nurse should be educated on the research regarding probiotics
when a patient is interested in trying alternative therapies in an effort to control an ulcerative
colitis flare up. A nurse should be aware that there is no scientific evidence to say that probiotics
are effective but that taking probiotics is generally safe with limited side effects if that patient
should decide to try it anyways. It is the nurse’s job as a patient advocate to help a patient
explore types of treatment and make sure that the patient is getting the treatment that he or she
wants. However, there is a need for more research in alternative therapies for patients with
ulcerative colitis. As shown in my research, there is no concrete scientific evidence to say that
probiotics can help induce remission and maintain bowel health. Likewise, no studies have
suggested that diet can either cause or treat ulcerative colitis. There is not even a specific
recommended diet that patients with ulcerative colitis should follow. Limited studies have shown
promise to various other remedies and alternative therapies such as curcumin, a derivative of the
herb turmeric, and parasitic worms. Similar to probiotics these studies have not shown that the
therapies are effective and should be recommended. Therefore, given all of this evidence, a nurse
needs to be a support system for the patient during frustrations during flare ups and in however
the patient and the doctor decide to treat it. Furthermore a nurse should also suggest that the
patient learn relaxation techniques in an effort to control stress, which is thought to be a cause of
flare ups. Additionally the nurse should suggest that the patient keep a food log to see if there
any foods that really upset his or her stomach so they can avoid them. In conclusion, there is a
desperate need for more research regarding alternative treatments for ulcerative colitis such as
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probiotics. Further well-designed, larger randomised controlled trials are needed to determine
whether probiotics can be as an alternative therapy or an addition to standard medicinal therapy
(Lynch & Bloomfield 2014).
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References
Cochrane Reviews. (2014, January 14). The Cochrane Collaboration. Retrieved May 2, 2014,
from http://www.cochrane.org/cochrane-reviews
Hibberd, P., Klein, M., Duffy, L., & Killen, J. (2012, December 12). Oral Probiotics: An
Introduction. <i>NCCAM</i>. Retrieved May 1, 2014, from
http://nccam.nih.gov/health/probiotics/introduction.htmReferences
Lynch, S., & Bloomfield, R. (2013, March 4). Ulcerative Colitis. . Retrieved May 2, 2014, from
http://patients.gi.org/topics/ulcerative-colitis/#basics_1
Mallon, P. T., McKay, D., Kirk, S. J., & Gardiner, K. (2007). Probiotics for induction of
remission in ulcerative colitis. Cochrane Database of Systematic Reviews, (4) Retrieved
from
http://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=2009825139&site=e
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Naidoo, K. (2011). Probiotics for maintenance of remission in ulcerative colitis. Cochrane
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Sang, L., Chang, B., Zhang, W., Wu, X., Li, X., & Jiang, M. (2010). Remission induction and
maintenance effect of probiotics on ulcerative colitis: A meta-analysis. World Journal of
Gastroenterology: WJG, 16(15), 1908-1915. Retrieved from
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