Dig Dis 2011;29:588–591
DOI: 10.1159/000332987
The Effect of Inactivated Lactobacillus LB
Fermented Culture Medium on Symptom Severity:
Observational Investigation in 297 Patients with
Diarrhea-Predominant Irritable Bowel Syndrome
A.L. Tarrerias V. Costil F. Vicari J.C. Létard P. Adenis-Lamarre A. Aisène D. Batistelli
G. Bonnaud S. Carpentier P. Dalbiès S. Ecuer J. Etienne M. Fantoli B. Grunberg
P. Lannoy J. Lapuelle A. Margulies M. Neumeier J.M. Rouillon L. Schmets
M.P. Pingannaud P. Coulom F. Kholer J.M. Canard
Service de Gastro-Entérologie, Hôtel-Dieu, Clermont-Ferrand, France
Key Words
Diarrhea ⴢ Health-related quality of life ⴢ Irritable bowel
syndrome ⴢ Microflora ⴢ Probiotics
Abstract
Introduction: Little is known about the intensity of symp-
toms of diarrhea-predominant IBS (IBS-D) or the conse-
quences of the disease on patients’ health-related quality of
life (HRQOL). This observational investigation assessed the
symptoms (abdominal pain, bloating, number of stools per
day, and stool consistency), impact on HRQOL, and conse-
quence on anal continence in 297 patients with IBS-D before
and after 1 month of probiotic treatment with Lacteol (inac-
tivated Lactobacillus LB plus fermented culture medium).
Methods: Functional assessment using a standardized visu-
al analogue scale in order to quantify abdominal pain, bloat-
ing, and quality of life before and after 1 month of treatment
with 2 capsules/day of Lacteol. The number of symptomatic
days per week, number of stools, consistency of stools, sec-
ondary fecal incontinence rate, and potential trigger effect
of food were quantified. A ␹2 test was used to compare qual-
© 2011 S. Karger AG, Basel
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Fax +41 61 306 12 34
E-Mail karger@karger.ch Accessible online at:
www.karger.com www.karger.com/ddi
itative data and the variance of quantitative criteria was ana-
lyzed. Results: The pain score decreased from 4.46 8 0.15 on
a scale of 0–10 before treatment to 2.8 8 0.14 after treatment
(p ! 0.0001). Bloating decreased from 4.49 8 0.18 to 2.5 8
0.15 on a scale of 0–10 (p ! 0.0001). The HRQOL score, which
is inversely correlated with quality of life, decreased from
5.99 8 0.14 to 3.92 8 0.16 (p ! 0.0001). In this cohort study,
the fecal incontinence rate secondary to diarrhea was clearly
higher than that of the general population: 18% versus a
prevalence of 9–10%, according to different studies. The
mean number of stools per week decreased from 17.59 to
12.83 after treatment (p ! 0.0001). Before treatment, 54% of
patients had watery stools and 46% had smooth stools; at
the end of treatment, only 18.5% of patients still had watery
stools, and 34% had normal stools. 52% of patients attrib-
uted their symptoms to their diet: 34% to vegetables, 29% to
fruit, 15% to milk, 15% to fat, 6% to peppers and spices, and
4% to sugar. Conclusion: This observational investigation
shed new light on patients with IBS-D, the HRQOL of which
is altered by a fecal incontinence rate twice as high as that of
the general population. Correlation with diet is confirmed by
1 out of 2 patients reporting poor tolerance of fiber and dairy
198.143.32.1 - 11/26/2015 1:57:10 AM
A.L. Tarrerias
Washington University
Service de Gastro-Entérologie
Hôtel-Dieu
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FR–63000 Clermont-Ferrand (France)
E-Mail al.tarrerias @ wanadoo.fr
products. Nutritional management should thus be part of
these patients’ treatment. Inactivated Lactobacillus LB plus
fermented culture medium is a probiotic drug that has been
used by physicians for a long time to treat patients with diar-
rhea. Strongly concentrated, it has no side effects and seems
to help these patients. Due to a strong placebo effect in pa-
tients with this pathology, however, a controlled study is
necessary to confirm this result.
Copyright © 2011 S. Karger AG, Basel
Introduction
It has been established that irritable bowel syndrome
(IBS) concerns 20% of the population if simple diagnos-
tic criteria are considered, but only 5% if the Rome cri-
teria are used [1, 2]. IBS reduces health-related quality of
life (HRQOL), which is often difficult to assess. More-
over, the physiopathology of IBS remains unclear, prob-
ably because there are a number of factors involved in-
cluding the enteric nervous system, inflammatory pro-
cesses, diet, and (recognized more recently) microbiota.
The role of intestinal flora is the digestion of sugar
through the process of glycolysis, the final substrates of
which are volatile fatty acids (acetate, butyrate, and pro-
pionate). These acids provide energy and seem to have
an effect on microinflammation [3]. The proteolytic ac-
tivity of some bacteria in the colon results in the release
of nitrogen and carbon, activating the process of putre-
faction. These bacteria also protect the intestine from
colonization of pathogenic bacteria. The composition of
intestinal flora is different from one individual to an-
other, and seems to be related to diet and the use of an-
tibiotics.
IBS sufferers have a tendency to practice very drastic
dietary exclusion [4], as there are no scientifically proven
one-size-fits-all recommendations [5]. Little is known
about the intensity of symptoms of diarrhea-predomi-
nant IBS (IBS-D) or the consequences of the disease on
patients’ HRQOL. Thus, the aim of this observational in-
vestigation was to better evaluate these patients’ symp-
toms and their HRQOL by quantifying them with a vi-
sual analogue scale. The population studied is composed
of patients consulting a gastroenterologist for IBS-D and
therefore does not represent only severely affected pa-
tients. A second objective was to test the effect of a probi-
otic drug, Lacteol LB, which has been used for many years
for symptomatic adjunct treatment of diarrhea, on base-
line quantitative and qualitative data.
Inactivated Lactobacillus LB Fermented
Culture Medium
18
16
14
Stools/week (n)
12
10
8
6
4
2
0
Before After
Fig. 1. Number of stools per week following 1 month of treatment
with Lacteol (p ! 0.0001).
Methods
This study was carried out by the Club de Réflexion des Cabi-
nets et Groupe de Gastroentérologie, which, through its commis-
sions, evaluates certain pathologies and the value of different
therapeutic interventions. The study included 297 patients, with
a mean age of 53.4 8 17.3 years, and involved 50 gastroenterolo-
gists. Each patient filled in a questionnaire designed to provide
both a qualitative and quantitative assessment of the disease. The
qualitative portion concerned the presence or absence of a rela-
tionship between symptoms and diet, and which foods were con-
sidered to trigger the disease, stool consistency, and episodes of
fecal incontinence. The quantitative portion measured the num-
ber of stools per week and used a visual analogue scale with a scale
of 0–10 to measure abdominal pain, bloating, and HRQOL. The
questionnaire was completed at the time of inclusion and again
after 1 month of treatment with Lacteol (2 capsules/day). The gas-
troenterologists involved in the study were working in private
practice; they prescribed Lacteol for its usual indication: symp-
tomatic adjunct treatment of diarrhea. A ␹2 test was used to com-
pare qualitative data and analysis of variance was used for quan-
titative data.
Results
Quantitative Data
The average number of stools per week decreased from
17.59 8 0.6 to 12.83 8 0.61 after treatment (p ! 0.0001)
(fig. 1). The score for abdominal pain decreased from 4.47
8 0.15 on a scale of 1–10 before treatment to 2.79 8 0.14
after treatment (p ! 0.0001) (fig. 2). The score for bloating
decreased from 4.49 8 0.18 to 2.56 8 0.15 (p ! 0.0001)
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Dig Dis 2011;29:588–591 589
Washington University
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7 many studies have reported a correlation between the pro-
Before
After
6
Symptom rating (VAS 1–10)
5 seems to show rather high scores with a mean of 4.5 on a
4 *
3 * * ty to the presence of gas in the colon, as it has been dem-
2 onstrated with barostat measurements that IBS-D patients
1
0 The mode of action of Lacteol is related to the prop-
Abdominal pain Bloating
Fig. 2. Effect of Lacteol on functional symptoms. VAS = Visual
analogue scale. *p ! 0.0001.
(fig. 2). The HRQOL score, which is inversely correlated
with quality of life, decreased from 5.99 8 0.14 to 3.92 8
0.16 (p ! 0.0001). In this cohort study, the fecal inconti-
nence rate secondary to diarrhea was clearly higher than
the prevalence in general population: 18% versus 9–10%,
according to different studies (fig. 2) [6].
Qualitative Data
Before treatment, 54% of the patients had watery stools
and 46% had smooth stools; at the end of the treatment,
only 18.5% of the patients still had watery stools and 34%
had normal stools. Fifty-two percent of patients attrib-
uted their symptoms to their diet: 34% to vegetables, 29%
to fruit, 15% to milk, 15% to fat, 6% to peppers and spices,
and 4% to sugar.
Discussion
Although many epidemiological studies have shown an
impairment of the HRQOL of IBS patients [7, 8], few have
focused on IBS-D only. Even though it is easy to under-
stand why diarrhea is a problem for an active person, we
did not expect such severe HRQOL scores, especially since
this cohort was composed of patients whose symptoms
were not particularly severe, with a mean number of
stools/day under 3 at the beginning of the study. The ur-
gent need to defecate and fecal incontinence probably play
a major role in the impairment of HRQOL; this improves
when the number and consistency of stools is corrected.
590 Dig Dis 2011;29:588–591
Bloating is also a symptom that hinders daily life, and
duction of gas and excessive fermentation that induces
slow transit [9]. However, our observational investigation
scale of 10. This does not necessarily correspond to hyper-
fermentation, but presumably to digestive hypersensitivi-
often show colic hypersensitivity [10]. This physiopatho-
logical condition should be further investigated.
Quality of life
erty of the probiotic (LB strain) to coat the colic mucosa,
thus protecting it against the adhesion and invasion of
pathogenic microorganisms – a mechanism implicated
in diarrhea of infectious origin. However, it is also thought
that the fermented culture medium also has targeted an-
tibacterial action towards some opportunistic germs [11]
or has a property to stimulate the acidogenic defense flo-
ra and IgA immunoglobulin synthesis, which has led to
the recommendation of Lactobacillus LB for diarrhea of
an infectious origin. However, as for all probiotics, its
mode of action remains theoretical and its effects on
functional bowel disorders and as a treatment of IBS are
poorly evaluated.
The efficacy of Lacteol in this open study with no con-
trol group is debatable, and the results should be con-
firmed by a controlled, randomized, double-blind study.
Xiao et al. [12] compared Lacteol to Lacidophilin (viable
Lactobacillus) in a controlled, randomized, double-blind
study including 137 patients. There was a significant dif-
ference in favor of Lacteol with regard to improved fre-
quency and consistency of stools, abdominal pain, and
bloating. This probiotic drug has been used for many
years for the treatment of diarrhea. The results of this
study were confirmed by Halpern et al. [13] in a cross-
over trial with Lacteol against placebo in 18 patients with
IBS-D that demonstrated the efficiency of Lacteol in half
of the patients. Although Halpern’s trial had a small co-
hort and Xiao’s study used viable Lactobacillus, both
studies corroborate the results found here for the same
symptoms and the visual analogue scale assessments.
Conclusions
This observational investigation offers further in-
sight into the important impact of IBS-D on HRQOL,
and shows an elevated rate of patients suffering from the
urgent need to defecate or secondary fecal incontinence.
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Tarrerias et al.
Washington University
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These data place IBS as a true disease for which the aim
should be the treatment of our patients and not only the
simple objective of comfort. The place of probiotics in
the management of this syndrome is increasing. Lacteol
is an interesting drug for the diarrheic form, and its ef-
ficiency should be confirmed by a randomized double-
blind study against placebo. This study unexpectedly re-
vealed a level of fecal incontinence in these patients
much higher than that of the general population; in the
future, a study specifically on the effect of Lacteol on fe-
cal incontinence induced by diarrhea should be per-
formed.

References
1 Jones R, Lydeard S: Irritable bowel syndrome
in the general population. BMJ 1992;304:87–
90.
2 Longstreth GF, Wolde-Tsadi KG: Irritable
bowel-type symptoms in HMO examinees.
Prevalence, demographics, and clinical cor-
relates. Dig Dis Sci 1993;38:1581–1589.
3 Osman N, Adawi D, Ahrné S, Jeppsson B,
Molin G: Probiotics and blueberry attenuate
the severity of dextran sulfate sodium (DSS)-
induced colitis. Dig Dis Sci 2008; 53: 2464–
2473.
4 Dainese R, Galliani EA, De Lazzari F, Di Leo
V, Naccarato R: Discrepancies between re-
ported food intolerance and sensitization
test findings in irritable bowel syndrome pa-
tients. Am J Gastroenterol 1999; 94: 1892–
1897.
5 Dapoigny M, Stockbrügger RW, Azpiroz F,
Collins S, Coremans G, Müller-Lissner S,
Oberndorff A, Pace F, Smout A, Vatn M,
Whorwell P: Role of alimentation in irritable
bowel syndrome. Digestion 2003; 67: 225–
233.
6 Parès D, Vial M, Bohle B, Maestre Y, Pera M,
Roura M, Comas M, Sala M, Grande L: Prev-
alence of fecal incontinence and analysis of
its impact on quality of life and mental
health. Colorectal Dis 2011;13:899–905.
7 Lee V, Guthrie E, Robinson A, Kennedy A,
Tomenson B, Rogers A, Thompson D: Func-
tional bowel disorders in primary care: fac-
tors associated with health-related quality of
life and doctor consultation. J Psychosom
Res 2008;64:129–138.
8 Minocha A, Johnson WD, Abell TL, Wiging-
ton WC: Prevalence, sociodemography, and
quality of life of older versus younger pa-
tients with irritable bowel syndrome: a pop-
ulation-based study. Dig Dis Sci 2006; 51:
446–453.
9 Agrawal A, Houghton LA, Reilly B, Morris J,
Whorwell PJ: Bloating and distension in ir-
ritable bowel syndrome: the role of gastroin-
testinal transit. Am J Gastroenterol 2009;
104:1998–2004.
10 Park JH, Rhee PL, Kim G, Lee JH, Kim YH,
Kim JJ, Rhee JC, Song SY: Enteroendocrine
cell counts correlate with visceral hypersen-
sitivity in patients with diarrhea-predomi-
nant irritable bowel syndrome. Neurogas-
troenterol Motil 2006;18:539–549.
11 Coconnier MH, Lievin V, Bernet-Canard
MF, Hudault S, Servin AL: Antibacterial ef-
fect of adhering human Lactobacillus aci-
dophilus strain LB. Antimicrob Agents Che-
mother 1997; 41:1046–1052.
12 Xiao SD, Zhang DZ, Lu H, Jiang SH, Liu HY,
Wang GS, Xu GM, Zhang ZB, Lin GJ, Wang
GL: Multicenter, randomized, controlled tri-
al of heat-killed Lactobacillus acidophilus LB
in patients with chronic diarrhea. Adv Ther
2003;20:253–260.
13 Halpern GM, Prindiville T, Blankenburg M,
Hsia T, Gershwin ME: Treatment of irritable
bowel syndrome with Lacteol Fort: a ran-
domized, double-blind, cross-over trial. Am
J Gastroenterol 1996; 91:1579–1585.

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Inactivated Lactobacillus LB Fermented Dig Dis 2011;29:588–591 591

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Culture Medium
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Erratum

In the article by Tarrerias et al. (Dig Dis 2011;29:588–591) the institutional address
should read: CREGG: Club de réflexion des cabinets et groupes d’Hépato-Gastroen-
térologie, Marseille, France and Hôpital Foch, Suresnes, France. The corresponding
address should read: A.L. Tarrerias, Hôpital Foch, 40, rue Worth, FR–92151 Suresnes
(France).

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