The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.
This is a phase IV, double- blind, randomized, placebo controlled, monocentric study. Males and women over 18 y.o. with Irritable bowel syndrome (IBS) diagnosed applying Rome III criteria will be enrolled consecutively. The study consist of 4 periods: * A screening's period of 2 weeks starting from visit 1, useful to screen potentially eligible patients performing diagnostic investigations necessary to confirm diagnosis. * A run- in's period, starting from visit 2 and lasting 2 weeks will represent a baseline without specific treatments in order to characterize the severity of symptomatology and evaluate patients' compliance relative to daily diaries * A 2 weeks- treatment's period ( active/ placebo) starting from visit 3. The 1st day of the period of treatment, eligible patients will be randomized following a 1:1 ratio to receive Proklama ( 1 sachet/ day) or placebo. Treatments will be administered daily during the whole 2 weeks- treatment's period. * A wash out's period lasting 2 weeks starting from visit 4, to be performed the day after the end of the 2 weeks- treatment's period. * A 2 weeks- treatment's period ( placebo/ active) starting from visit 5, to be performed the last day of wash out's period. During this visit patients will receive the second treatment, following a crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Policlinico San Matteo Pavia Fondazione IRCCS
Pavia, Italy
Recorded pain in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of the most severe pain occurred in the previous 24 hours. Pain severity is scored 0-10 ( 0= absent; 10= pain as bad as can be).
Time frame: 24 h
Recorded abdominal distension in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of abdominal distension occurred in the previous 24 hours. Abdominal distension is scored 0-10 ( 0= absent; 10= abdominal distension as bad as can be).
Time frame: 24 h
Recorded abdominal discomfort in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of abdominal discomfort occurred in the previous 24 hours. Abdominal discomfort is scored 0-10 ( 0= absent; 10= abdominal discomfort as bad as can be).
Time frame: 24 h
Recorded abdominal meteorism in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of abdominal meteorism occurred in the previous 24 hours. Abdominal meteorism is scored 0-10 ( 0= absent; 10= abdominal meteorism as bad as can be).
Time frame: 24 h
Recorded flatulence in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of flatulence occurred in the previous 24 hours. Flatulence is scored 0-10 ( 0= absent; 10= flatulence as bad as can be).
Time frame: 24 h
Recorded borborygmi in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of borgorygms occurred in the previous 24 hours. Borborygmi is scored 0-10 ( 0= absent; 10= borborygmi as bad as can be).
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Time frame: 24 h
Recorded nausea in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of nausea occurred in the previous 24 hours. Nausea is scored 0-10 ( 0= absent; 10= nausea as bad as can be).
Time frame: 24 h
Recorded belching in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of belching occurred in the previous 24 hours. Belching is scored 0-10 ( 0= absent; 10= belching as bad as can be).
Time frame: 24 h
Recorded asthenia in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of asthenia occurred in the previous 24 hours. Asthenia is scored 0-10 ( 0= absent; 10= asthenia as bad as can be).
Time frame: 24 h
Recorded headache in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of headache occurred in the previous 24 hours. Headache is scored 0-10 ( 0= absent; 10= headache as bad as can be).
Time frame: 24 h
Recorded "empty- head" feeling in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of "empty- head" feeling occurred in the previous 24 hours. "Empty- head" feeling is scored 0-10 ( 0= absent; 10= "empty- head" feeling as bad as can be).
Time frame: 24 h
Recorded attention deficity in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of attention deficity occurred in the previous 24 hours. Attention deficity is scored 0-10 ( 0= absent; 10= attention deficity as bad as can be).
Time frame: 24 h
Recorded vomiting feeling in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of vomiting occurred in the previous 24 hours. Vomiting feeling is scored 0-10 ( 0= absent; 10= vomiting as bad as can be).
Time frame: 24 h
Recorded heartburn in a diary using a 11-points Numeric Rating Scale (NRS)
Self reported evaluation of heartburn occurred in the previous 24 hours. Heartburn is scored 0-10 ( 0= absent; 10= heartburn as bad as can be).
Time frame: 24 h
Number of evacuations recorded in a diary
Self reported record of number of evacuations in the previous 24 h.
Time frame: 24 h
Recorded stool consistency in a diary using a 7- point Bristol Stool Form Scale
Self reported evaluation of stool consistency occurred in the previous 24 hours. Stool consistency is scored 1- 7 ( 1= constipation; 7=diarrhoea)
Time frame: 24 h