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| Name | Class |
|---|---|
| Instituto de Nutrición y TecnologÃa de los Alimentos | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Alflorex® The participants consume one probiotic capsule a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alflorex® | Dietary Supplement | Each probiotic capsule contains 1 x 10^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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." | 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) | Change from baseline, assessed at 6 and 12 weeks of supplement intake |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline, assessed at 6 and 12 weeks of supplement intake |
| Change in stool consistency assessed using the Bristol Stool Form Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen Murphy, PhD | PrecisionBiotics Group Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Nutrición y TecnologÃa de los Alimentos, Universidad de Chile | Santiago | Chile |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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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. |
| Change from baseline, assessed at 6 and 12 weeks of supplement intake |
| Change in stool frequency | Assessed from patient diaries | Change from baseline, assessed at 6 and 12 weeks of supplement intake |
| Change in days absent from school | Assess from patient diaries | Change from baseline, assessed at 6 and 12 weeks of supplement intake |