The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in children with Functional Gastrointestinal Disorders (FGIDs).
This is an open label study to assess the safety and effectiveness of Bifidobacterium longum 35624® Alflorex® when consumed once daily by children with Functional Gastrointestinal Disorders (FGIDs). The 12-week intervention study will be conducted in 63 non-coeliac children aged 8 to 18 years old with an FGID who experience at least two episodes of abdominal pain per week. The study will consist of 5 visits over a 14 week period commencing with a screening visit. The second visit will be the baseline (start of intervention), followed by third (mid-intervention), fourth (end of treatment) and fifth (follow up) visit. Questionnaires will be administered from the second to the fifth visit. A blood sample will be taken before treatment to rule out coeliac disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Each probiotic capsule contains 1 x 10\^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate.
Instituto de Nutrición y Tecnología de los Alimentos, Universidad de Chile
Santiago, Chile
Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS)
The IBS-SSS measures symptom severity in IBS patients and is a reliable and validated questionnaire taking into account the composite score of abdominal pain, number of days with abdominal pain, bloating/distention, satisfaction with bowel habits and IBS-related quality of life. For this study, an adapted version was used in conjunction with the NRS-11 pain scale for the purposes of accurately capturing the response of a pediatric population. The NRS-11 pain scale goes from 0-10 with 0 indicating "no pain" and 10 indicating "very severe pain."
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in abdominal pain assessed by the Numeric Rating Scale for pain
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain which goes from 0 (no pain) to 10 (worst pain)
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in quality of life assessed by the Irritable Bowel Syndrome-Quality of Life questionnaire
The IBS-QOL scoring is from 0 to 100, with higher scores indicating better IBS specific quality of life
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in stool consistency assessed using the Bristol Stool Form Scale
The Bristol Stool Form Scale classifies stool according to shape and consistency and assigns a sample a number from 1-7 depending on its characteristics, corresponding to constipation normal or diarrhea.
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in stool frequency
Assessed from patient diaries
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Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in days absent from school
Assess from patient diaries
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake