INTERNATIONAL JOURNAL OF FOOD SCIENCES AND NUTRITION 3
Table 1. Schedule of visits, and activities carried out during each visit. Day visit no. – description Day -14 to -21 1 – Screening Day 0 2 – Baseline
Day 28 3 – End of Study
Visit Window
þ 7 days
þ 7 days
Informed Consent Inclusion/Exclusion
X X X X X X
X
General medical history Demographic data Urine pregnancy test Subject daily diary provided
X X X X
PAC-QOL PAC-SYM
X X
Study product administered Study product returned Adverse events/SAE recorded
X X X
X X
Prior/Concomitant Medications Record
X
Table 2. Summary of subject demographics. Treatment group Demographic Lepicol ( n ¼ 35)
(Protexin), Somerset, UK) twice daily, approximately 30 min before a main meal (morning and evening). The sachet was stirred into a glass of cold water and con- sumed, followed by an additional glass of water imme- diately. The subjects consumed the first dose in the clinic where the product was dissolved in 240 ml of water, and followed by an equal volume of water. Each 5 g sachet contained 3.45 g of psyllium husks ( Plantago ovata forsk ), 1.5 g of inulin and 6 10 8 CFU combined total of the following probiotic strains, Lactobacillus rhamnosus PXN 54 (NCIMB 30188), Bifidobacterium bifidum PXN 23 (NCIMB 30179), Lactobacillus acid- ophilus PXN 35 (NCIMB 30184), Lactobacillus planta- rum PXN 47 (NCIMB 30187) and Lactobacillus bulgaricus PXN 39 (NCIMB 30186). These strains have demonstrated antimicrobial activity against a number of pathogens, possibly through the production of lactic and acetic acid (Tejero-Sarinena et al. 2012). In add- ition, these strains have shown good survivability in vitro at pH 2.0 (Probiotics International Ltd, data on file). The placebo (also provided by Probiotics International Ltd) was provided in 5 g sachets and con- tained 4.975 g of fine rice starch and 0.025 g of magne- sium stearate (an excipient to assist in the flow during the manufacturing process). The packaging of both products was identical. Efficacy assessments and endpoints Daily symptoms were recorded in a subject diary which included the number of bowel movements, and for each bowel movement they were asked to score the Bristol stool type (7 point scale), and to indicate if they had any of the following Rome III symptoms for the bowel movement – straining, incomplete evacu- ation, blockage in rectum, support pelvic floor/digital assistance. Subjects also recorded in their daily diaries if they used any medication or laxatives or felt unwell during the period. At the baseline and final study
Placebo ( n ¼ 34) 31 (91.2%)
p -Value
.673 a .614 a .398 b .505 c
Gender – female Race – Caucasian
33 (94.3%) 34 (97.1%)
32 (94.1%)
Age
45.09 ± 15.09 71.57 ± 14.80 164.78 ± 7.10
42.21 ± 12.88 72.76 ± 16.07 167.45 ± 8.02
Weight (kg) Height (cm)
.148 b Data are expressed as mean ± standard deviation for continuous variables, and categorical variables as absolute frequency and percent (for group).
a Fisher ’ s exact test. b Independent t -test. c Mann – Whitney test.
unstable and untreated disease or any condition which contraindicated, in the investigator ’ s judgement, entry to the study; malignant disease or any concomitant end-stage organ disease; obstructive or metabolic aeti- ology for constipation; history of laxative abuse (greater than the daily dosage recommended on the label for any laxative); history of drug and/or alcohol abuse at the time of enrolment; having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; individuals who, in the opinion of the investigator, were considered to be poor attendees or unlikely for any reason to be able to comply with the trial; subjects may not be receiving treatment involving experimental drugs; if the subject participated in a recent experimen- tal trial, this must have been completed not less than 90 days prior to this study. All subjects were requested to refrain from con- suming any probiotic-containing product but other- wise to maintain their routine diet and physical activity during the study period. Study product The participants were instructed to consume a 5 g sachet of Lepicol V R (Probiotics International Ltd
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